December 7, 2006
Cardium's Generx Advances to Phase 3 Following Meeting with FDA
(source: Cardium Therapeutics, Inc.)
The company announced that Generx™ (alferminogene tadenovec) is to be advanced to a Phase 3 clinical trial in women as a potential treatment for myocardial ischemia (insufficient blood flow within the heart muscle), following a meeting with the U.S. Food and Drug Administration (FDA). Generx represents a new therapeutic class of biologics designed to promote angiogenesis, a natural process of blood vessel growth within the heart muscle, following a one-time intracoronary administration from a standard cardiac infusion catheter. “Generx is the first and only DNA-based cardiovascular therapeutic to be advanced to Phase 3, and is believed to be the only current Phase 3 product candidate for the potential treatment of stable angina, a chronic medical condition affecting millions of patients in the U.S. and elsewhere,” stated Christopher J. Reinhard, Cardium’s Chairman and Chief Executive Officer.

November 30, 2006
Cardium Announces Formation of Scientific Advisory Board
(source: Cardium Therapeutics, Inc.)
Cardium Therapeutics, Inc. today announced the formation of a 6-member Scientific Advisory Board (SAB). The SAB, which includes physicians, clinicians, and biotechnology industry professionals, will provide counsel on a broad range of scientific and product development issues." We are extremely pleased to have this distinguished group of leading scientists and physicians join Cardium's inaugural Scientific Advisory Board," stated Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer. "Their deep knowledge and experience will be important as we look to advance our product candidates currently in development toward commercialization."

November 30, 2006
NYS Report Ranks LIJ, North Shore University Hospital Among New York's Best for Angioplasty Survival (source: North Shore - Long Island Jewish Health System)
“Long Islanders should be thankful to know that of the five hospitals in their region reviewed in the state Health Department’s most recent report, three had outcomes that were the best in the state,” said Dennis Dowling executive director of NSUH and LIJ, noting that Winthrop University Hospital in Mineola was the only other hospital in the state besides North Shore and LIJ to achieve the double-star designation. “In this era of public disclosure of clinical outcomes, patients and their families should take the opportunity to avail themselves of this highly useful data compiled by the state.”

November 13, 2006
American College of Cardiology and Partners Launch National Alliance To Reduce Door-to-Balloon (D2B) Times
The American College of Cardiology (ACC), together with the American Heart Association (AHA) and other key national healthcare organizations, announces the launch of its latest quality campaign, “Door to Balloon (D2B): An Alliance for Quality”, aimed at improving the timeliness of lifesaving therapy for patients with heart attacks at the nation’s hospitals that perform emergency angioplasty. (Read more...)

October 24, 2006
Cardium Reports on Positive Effects of Hypothermia Following Heart Attack and Announces Clinical Study to Be Co-Sponsored by Swedish Cardiology Center
(source: Cardium Therapeutics, Inc.)
Cardium Therapeutics and its subsidiary InnerCool Therapies today reported on preclinical data demonstrating a new and expanded benefit of early rapid cooling for the potential treatment of acute myocardial infarction (heart attack), as presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2006 Annual Meeting in Washington, DC. The data showed that cooling prior to PCI reduced overall infarct size (reflecting tissue damage) by an additional 40%. These findings strongly support the use of early rapid cooling in planned clinical studies, and suggest that InnerCool's endovascular cooling system may have the potential to enable interventional cardiologists to dramatically reduce tissue damage following a heart attack.

October 16, 2006
Paragon Intellectual Properties Announces Funding Commitments of $15 Million
(source: Paragon Intellectual Properties, LLC)
A new West Virginia start-up device company is opening an R&D center in southern California to develop new stents, nanotechnology, and other innovations -- funded by a $15 million in financing from private investors and equity stakes made by both Abbott and Boston Scientific. (Read more...)

October 12, 2006
David Kandzari, M.D., International Expert in Interventional Cardiology, Named Chief Medical Officer of Cordis Cardiology
(source: Cordis Corporation)
Cordis has announced that effective December, Dr. Kandzari will oversee medical and clinical affairs for the company. Dr. Kandzari becomes the fourth high profile interventional cardiologist to join a medical device firm in the past year.

October 2, 2006
Bypass Surgery Tops Angioplasty for Sickest Heart Patients
(source: Duke University Medical Center)
Bolstering some studies that have been discussed for years, Duke's analysis shows that the sickest patients, mainly those with diffuse, multivessel coronary artery disease may best be served by Coronary Artery Bypass Grafting (CABG) rather than angioplasty. Survival rates were 5.3 months longer in the surgically-treated patients, as opposed to those who had angioplasty and stents. A very important caveat to this study is that the data predated the introduction of drug-eluting stents, which have been shown to significantly reduce restenosis and reclogging. Whether these will show a prolonging of life and change the surgery vs. angioplasty debate can only be verified by future studies. Another concern is whether the recent reports about the incidence of late stent thrombosis in drug eluting stents will significantly affect patient outcomes.

September 26, 2006
FDA Approves Cordis Carotid Stenting System
(source: Cordis Corporation)
Cordis announced that the FDA has approved its PRECISE® Nitinol Stent and ANGIOGUARD® Emboli Capture Guidewire system for use in opening up and stenting carotid arteries. This device now joins the two other carotid stent systems on the market in the U.S. -- Abbott's Xact/Emboshield system and the ACCULINK/ACCUNET system that was created by Guidant, but is now also owned by Abbott.

September 23, 2006
Report States FDA Drug Safety System is Broken
In a sweeping critique of the way in which the U.S. Food and Drug Administration (US FDA) currently monitors the safety of drugs, a blue ribbon panel of the Institute of Medicine (IOM), part of the National Academies, has issued a 350 page report that calls for greatly increased funding and action from Capitol Hill. (Read more...)

September 23, 2006
"I drove home and reached for three of the most useful medicines I know: aspirin, acetaminophen (Tylenol) and the Internet"
Commentary on an Op-Ed piece in the New York Times by Jerry Avorn of Harvard Medical School about the dissemination of useful medical information. (Read more...)

September 21, 2006
Dr. Michael Morgan Reports on Benefits of InnerCool's Celsius Control System in Inducing Hypothermia During Aneurysm Surgery
(source: Cardium Therapeutics, Inc.)
At a meeting of the Neurosurgical Society of Australasia, the experience in 26 patients with cooling the brain via catheter during aneurysm surgery in order to limit damage was reported on -- the outcomes being very positive.

September 19, 2006
Benefits of Vasomedical's EECP Therapy in Heart Failure Presented at the 10th Annual HFSA Scientific Meeting
(source: Vasomedical, Inc.)
Data was presented by physicians from New Delhi, India to St. Peterburg, Florida and Stony Brook, New York to show improvements in heart failure patients in a number of areas, among them exercise capacity, quality of life and angina.

September 12, 2006
Angioplasty.Org Cited as Model in Australian Government Campaign to Improve Physician-Patient Communication
The Australian National Health and Medical Research Council has used Angioplasty.Org as a resource and case study, in a newly published 163-page healthcare toolkit intended to improve practices in physician-patient communication. "Angioplasty.Org provides information and tools to help patients make informed decisions about heart disease treatment," explains Deborah Shaw, Angioplasty.Org Education Editor. "It's great validation to see content we publish recognized by the NHMRC and recommended to healthcare professionals and consumers throughout Australia.
(Read more...)

August 31, 2006
U.S. Court Grants Injunction Against Generic Plavix
A U.S. District Court today granted Sanofi/Bristol-Myers' request for a preliminary injunction against Apotex, prohibiting the Canadian-based firm from selling their generic clopidogrel product while the dispute over the validity of Sanofi's branded Plavix is decided. (Read more...)

August 30, 2006
Abbott Announces Completion of Enrollment in Groundbreaking Vulnerable Plaque Study
Utilizing the Volcano Therapeutics' intravascular ultrasound imaging system, the PROSPECT study, headed by Dr. Gregg Stone of Columbia University Medical Center in New York, will attempt to more clearly define who is at risk for a heart attack by looking at vulnerable plaque, not just plaque "build-up". (Read more...)

August 29, 2006
Positive PEECH Trial Results and Related Article Highlighting Mechanism of Action Published in the Journal of the American College of Cardiology
(source: Vasomedical, Inc.)
Enhanced External Counterpulsation (EECP) is a noninvasive, outpatient therapy for the treatment of diseases of the cardiovascular system currently indicated for use in cases of stable or unstable angina, congestive heart failure, acute myocardial infarction and cardiogenic shock. The upcoming issue of the Journal of the American College of Cardiology features an article (abstract below) detailing the positive benefits of this therapy for patients with refractory angina. The article concludes:

EECP treatment reduces arterial stiffness and improves wave reflection characteristics in patients with refractory angina. These changes decrease LV afterload and myocardial oxygen demand and reduce the number of angina episodes, therefore enabling patients to participate in continuous exercise programs which in turn may provide long-term benefits and sustained improved quality of life.

The JACC article did not set out to determine the long-term effects of the therapy, but a number of patients have posted their anecdotal experiences with EECP in Angioplasty.Org's Discussion Forum (link below)
related stories:
Enhanced External Counterpulsation Treatment Improves Arterial Wall Properties and Wave Reflection Characteristics in Patients With Refractory Angina -- Journal of the American College of Cardiology
Experiences with Enhanced External Counterpulsation (EECP) -- Discussion Forum -- Angioplasty.Org

August 28, 2006
Gerald Ford discharged after successful angioplasty
Former President Gerald Ford, age 93, underwent successful angioplasty on Friday, including placement of two stents. The procedure was done at the Mayo Clinic in Rochester, Minnesota. (Read more...)

August 22, 2006
New York Times: "In an Ohio City, Heart Procedure is Off the Charts"
A regional hospital in the small city of Elyria, Ohio got some publicity last Friday morning that they may have preferred not to. The EMH Regional Medical Center was the subject of a front page story in the New York Times on August 18. At the center of the story is the very high rate of angioplasty procedures performed on Medicaid patients at this hospital: almost four times the national average. The article notes that the outcomes for the hospital are very good -- its heart program has been highly rated -- but there are many questions raised by the article, and by the study on which it was based. (Read more...)

August 15, 2006
Patient Power: Making Sure Your Doctor Really Hears You
(source: Deborah Franklin, New York Times)
Very good article for patients (and physicians) in the New York Times Health section, discussing the "communications gap" between doctors and their patients, and some suggestions for improvement. The article surveys opinions from those in a new book titled, “You: The Smart Patient: An Insider’s Handbook for Getting the Best Treatment,” by doctors Michael F. Roizen and Mehmet C. Oz to medical sociologist Richard Frankel of Indiana University, who worked on a physician training program now used by Kaiser Permanente. The piece also discusses the role of the Internet in this relationship, quoting Dr. Carma Bylund of Sloan-Kettering as saying "Some patients now come armed with sheaves of journal articles and printouts, and demands for specific treatment." Angioplasty.Org hears the same statement from virtually every cardiologist queried.
related stories:
You and Your Physician -- Angioplasty.Org Patient Center

August 9, 2006
Marvin L. Woodall Named CEO of Cardiovascular Research Foundation
(source: Cardiovascular Research Foundation)
Marvin L. Woodall, a long-standing member of the Board of Directors of the Cardiovascular Research Foundation (CRF), was named the Chief Executive Officer (CEO) of the organization effective immediately. The organizations's press release states that "The position of CEO is newly created in an effort to both manage the tremendous growth experienced by CRF over the past several years as well as to lead the Foundation in new endeavors in the future." The CRF produces the annual TCT meeting each fall in Washington DC (this year from October 22-27).

August 8, 2006
Generic Version of Plavix® (Clopidogrel) is Launched by Apotex
In a bold and risky move, Apotex has launched a generic version of the top-selling antiplatelet drug Plavix. The generic drug, clopidogrel bisulfate, was approved by the U.S. Food and Drug Administration in January. Plavix is a blood thinner, taken by millions of heart patients and prescribed for all drug-eluting stent patients to lower the possibility of "stent thrombosis", a serious and sometimes fatal clotting of blood inside of the stent. (Read more...)

July 28, 2006
Will Multislice CT Angiography Replace Catheterization?
A study from the Cleveland Clinic was published earlier this week in JAMA comparing multidetector computed tomography ((a.k.a. Multislice CT) to the more invasive catheter-based angiography, currently considered the "gold standard" for measuring the blockage in coronary arteries. News media reports on the study were mixed. So one might wonder exactly what the study means for patients: are CT coronary scans good or not? (Read more...)

July 25, 2006
SHAPE Guidelines On Diagnosis Generate Heated Controversy
These recommendations were characterized in one medical publication as "a bold new report", yet in another they were labeled as "scientifically extremely questionable" and they "should be repudiated". In the public realm, today's Boston Globe ran a feature story questioning the apparent conflict of interest involved by who paid for the publication of the guidelines, which ran as a supplement in the July 17 issue of the American Journal of Cardiology. (Read more...)

July 21, 2006
Hospitals snap up 64-slice heart scanners
(source: Alan Bavley, The News-Sentinel, Fort Wayne, Indiana)
This feature article covers a wide range of topics concerning the rapidly growing use of 64-slice CT scans to diagnose coronary artery disease, a subject not without controversy. The article states an oft-quoted fact, that one-third of all diagnostic cardiac catheterizations (angiograms) turn out to be normal. Most current studies of Multislice CT scans show a negative predictive value in the high 90's (the patient does not have significant disease) -- at a cost that 10% of a standard angiogram and non-invasive.
related stories:
Multislice CT Angiogram -- Angioplasty.Org
Interview with Daniel S. Berman, MD -- Angioplasty.Org

July 10, 2006
New guideline for screening apparently healthy individuals to prevent a heart attack
(source: Association for Eradication of Heart Attack)
A group of influential cardiologists, imaging and other specialists has produced a dynamic and somewhat controversial report, which appeared as a supplement to today's American Journal of Cardiology. In it, the authors call for carotid ultrasound and CT scanning for all "at risk" men and women, defined as those men over 45 and women over 55 who meet one or more of the following risk factors, even if they have no symptoms: raised cholesterol (> 200mg/dL), high blood pressure (> 120/80 mm Hg), diabetes, family history of heart disease, metabolic syndrome or smoking. The task force named themselves SHAPE (Screening for Heart Attack Prevention and Education). (Read more...)

June 27, 2006
Congressman's Inquiry Finds F.D.A. Enforcement Down 54% Under Bush Administration
The senior Democrat on the House Government Reform Committee, Congressman Henry A. Waxman of California, issued the results of his 15-month investigation into enforcement actions undertaken by the U.S. Food and Drug Administration (FDA) and found that last year the Agency issued 535 warning letters to medical device or pharmaceutical companies -- this was compared to the year 2000, when 1,154 letters were issued -- a 54 percent decline and the lowest number in 15 years -- Waxman terms this "a precipitous drop in FDA enforcement actions". (Read more...)

June 26, 2006
Boston Scientific Recalls Some Pacemakers and Defibrillators
Boston Scientific announced that it is "retrieving" from hospital inventories and its sales force a specific subset of units that span various models of heart rhythm devices. The problem, which the company says is low in frequency, has to do with a low-voltage capacitor that has been performing below expectations and may cause a variety of device failures or premature battery depletion. (Read more...)

June 8, 2006
New Stent Delivery System Allows Physicians to Treat Life-Threatening Biliary Blockages
(source: Cordis Corporation)
Cordis today launched the PALMAZ® BLUE™ .014 Transhepatic Biliary Stent -- this is their latest biliary stent, a device which is often used to open blockages in the bile ducts to promote the flow of fluids from the liver, gallbladder and pancreas to the small intestines. Their press release states that each year, more than 30,000 Americans are affected by life-threatening blockages in the bile ducts, leading to the need for treatment.

June 8, 2006
'Balloon op' could cut deaths by a third
(source: Claire Lomax, This is Bradford, UK)
A news feature from a northern England paper discusses how angioplasty can stop a heart attack and save lives. Bradford Royal Infirmary patients are now taken by ambulance to Leeds General Infirmary where they will be fast-tracked to undergo immediate emergency angioplasty.
related stories:
Heart Attack and Angioplasty -- Angioplasty.Org

June 7, 2006
Papers Show Guidant Considered Warning Doctors of Hazards But Didn't Send Letter
(source: Barry Meier, New York Times)
An article in today's New York Times by Barry Meier, the reporter who "broke the news" about defects in Guidant defibrillator and CRT units last year, reports that papers released to the Times by a Texas judge show that Guidant had prepared a "Dear Doctor" letter in January 2005 explaining defects in its Contak Renewal devices, but apparently decided against sending it. An inquiry by the US FDA and Justice Department has been ongoing and the NYT article states that this evidence suggests "the legal and financial consequences from that inquiry could be significant for Guidant and Boston Scientific, which completed its acquisition of Guidant in April." Boston Scientific wouldn't comment on the specifics, but did state, "We understand and acknowledge the need for more timely and transparent communication. We are committed to doing a better job of communication with patients and physicians." The letter is one of 22 documents requested by the New York Times and are among 600,000 pages that had been submitted to the Texas court as part of a product liability case. The Times has been seeking these documents and it was only after an emergency appeal by Guidant attorneys was rejected that the documents were released. The judge has given Guidant until the close of business today to show why the rest cannot be released as well.
related stories:
Ruling Could Put Guidant Documents On Display -- Wall Street Journal $$
Boston Scientific unit faces suit -- Bloomberg News, via the Boston Globe
Guidant Letter About Risks Never Sent -- Mark Jewell, Associated Press

June 6, 2006
Effect of Door-to-Balloon Time on Mortality in Patients With ST-Segment Elevation Myocardial Infarction
(source: McNamara, Krumholz et al, Journal of the American College of Cardiology)

June 6, 2006
Boston Scientific Launches New Balloon Catheters Designed to Address Wide Variety of Peripheral Intervention Needs
(source: Boston Scientific Corporation)
These two Sterling™ balloons in monorail and over-the-wire configurations were actually cleared for marketing by the FDA back in December 2005 and are just now being launched. The FDA 510(k) clearance stated that these new balloons are "considered to be substantially equivalent to the Ultra-Soft SV Balloon Dilatation Catheter" that Boston Scientific has marketed since 2002. In January 2006 the company received a warning letter from the FDA that effectively put on hold any future approvals for Class III devices (the Sterling balloons are Class II and, as stated, were approved prior to the warning letter).
related stories:
510(k) Summary for Sterling™ Over-The-Wire Balloon Catheter -- Food and Drug Administration (PDF)
510(k) Summary for Sterling™ Monorail Balloon Catheter -- Food and Drug Administration (PDF)

June 5, 2006
Cardium Reports Meta-Analysis of Angiogenic Gene Therapy Studies Shows Positive Effects in Men and Women With Heart Disease
(source: Cardium Therapeutics, Inc.)
Dr. Timothy D. Henry, an interventional cardiologist and Professor of Medicine at the Minneapolis Heart Institute, presented an analysis of the AGENT clinical data on Saturday at the 9th Annual Meeting of the American Society of Gene Therapy (ASGT). The data, which relates to Cardium's lead product candidate, Generx™ (Ad5FGF-4) showed positive results in both men and women treated. Anginal pain was reduced significantly in patients vs. placebo. Previously reported reductions in symptoms at 6 months were maintained at one year. Additionally exercise capacity on a treadmill test increased for those patients over 55 who previously could not exercise for more than 5 minutes. The exercise capacity continued to increase between 6 months and one year, even though the therapy consists of a one-time infusion of the angiogenetic agent. Cardium is planning to launch further clinical trials later this year. Stay tuned -- Angioplasty.Org will soon be launching a special section on the exciting new frontier of angiogenesis in the treatment of heart disease.

June 5, 2006
Heart attack, bypass patient less fit than previously thought
(source: American Heart Association)
That goes for stent and angioplasty patients as well! The importance of cardiac rehabiliation in the recovery of patients is stressed in this report, as stated by Philip A. Ades, M.D., lead author and professor of medicine and director of Preventive Cardiology and Cardiac Rehabilitation at the University of Vermont College of Medicine in Burlington. “The biggest surprise was how low the fitness levels were in women. The average woman in this study fell in the fitness range where cardiologists often consider heart transplantation in heart failure patients. The take-home message to cardiac surgeons and interventional cardiologists is that the job is only half-done when bypass surgery or coronary stenting is satisfactorily performed. These patients remain sorely in need of rehabilitation despite optimal in-hospital care.”

June 5, 2006
FoxHollow Technologies Names Dr. John Simpson Chief Executive Officer
(source: FoxHollow Technologies, Inc.)
Angioplasty pioneer Dr. John Simpson, who founded FoxHollow, has now been named CEO. Simpson had been serving as interim CEO since the retirement of Robert W. Thomas in January.

June 2, 2006
Medtronic Announces Key Milestones in Endovascular Repair at Society for Vascular Surgery Meeting
(source: Medtronic, Inc.)
At the 60th annual Society for Vascular Surgery meeting Medtronic celebrated several milestones in its company history of pioneering endovascular device manufacturing, among them over 10 years and 100,000 endografts placed (for abdominal aortic aneurysms or thoracic lesions). The importance of these devices was summed up by Katie Szyman, VP and general manager of Medtronic's Endovascular business: "The advent of stent graft therapy has given patients an effective, minimally-invasive alternative to open surgery, with reduced recovery times and potentially improved survival rates." The development of the endovascular field is chronicled in our video documentary below.
related stories:
"Vascular Pioneers: Evolution of a Specialty" -- video from Vasculartherapy.Org

June 1, 2006
Dr. Gabor Rubanyi of Berlex Biosciences Joins Cardium as Chief Scientific Officer
(source: Cardium Therapeutics, Inc.)
In this company press release, Chairman/CEO Christopher J. Reinhard states, "We are pleased to welcome Dr. Rubanyi to Cardium Therapeutics. Gabor and I worked together over the past decade as Berlex and Collateral Therapeutics collaborated on the discovery, pre-clinical research and clinical development of our lead product, Generx, for the potential treatment of coronary heart disease. His extensive experience in angiogenic therapy with Schering/Berlex has been instrumental in our growth and evolution and he will continue to play a key role as we prepare to advance Generx into late-stage clinical studies."

May 31, 2006
Cordis Announces Nationwide Introduction of Breakthrough Devices to Treat Artery Blockages in Leg
(source: Cordis Corporation)
Cordis Endovascular, division of Cordis Corporation, today announced the nationwide introduction of two breakthrough devices, FRONTRUNNER® XP CTO and OUTBACK® LTD™ Re-Entry Catheters to treat artery blockages in the lower leg, a common finding in patients with diabetes and peripheral vascular disease. Both devices facilitate angioplasty and stenting in chronic total occlusions (CTO) which are complete or nearly complete blockages that can lead to surgery or lower leg amputation. Previously, many patients with CTOs did not have access to these less-invasive procedures because to treat CTOs with less-invasive methods, a doctor must first cross through the blockage. The FRONTRUNNER® XP CTO and OUTBACK® LTD™ Re-Entry Catheters allow physicians to break through complete blockages allowing treatment with stents or balloons. By using these catheters, patients may avoid having to undergo difficult surgeries or even amputations. The devices were developed by Lumend, Inc. of Redwood City, California -- Cordis acquired Lumend last September.

May 31, 2006
FDA Approves Xpert™ Study -- First U.S. Study of Stent Placement to Treat Arterial Blockages Below the Knee
(source: VIVA Physicians, Inc.)
The XCELL Trial expects to enroll 140 patients in 10 centers to study the efficacy of Abbott Vascular's Xpert self-expanding nitinol stent in treating severe peripheral arterial disease (PAD) below the knee. The Xpert is currently approved for use in the U.S. to treat blockages in the biliary ducts that carry digestive enzymes from the liver. This first-of-kind study in the U.S. will determine It is estimated that 25 million people suffer from blockages in the arteries of the lower leg. Principal investigator Dr. James Joye, D.O., of El Camino Hospital in Mountain View states, "Those with advanced disease may be poor candidates for surgery and have few treatment options. Many are at high risk of losing a limb.... This is an important trial to expand patient treatment options, increase physician awareness and take an important step forward in preventing amputation."

May 31, 2006
FDA Clears Boston Scientific System for Removing Clots from Arteries
(source: Boston Scientific Corporation)
The company has received clearance from the U.S. Food and Drug Administration (FDA) to market its Rio™ Aspiration Catheter. The new device is indicated for use in the removal of thrombi, or clots, from vessels throughout the body. Clots can restrict or block blood flow in an artery, creating difficulty or risk to a patient when undergoing intravascular procedures. The Rio Aspiration Catheter can be used with other interventional devices, such as those used to place stents, to open blockages caused by clots in the target area within a vessel.

May 30, 2006
St. Francis and Temple University Hospitals Expand Vascular Imaging Capabilities with New Toshiba Infinix DP-i/FD2
(source: Toshiba America Medical Systems)
Toshiba's new system, introduced in March, is the only single lab that meets American College of Cardiology guidelines for both cardiac and peripheral work. The availability of this system and its adoption reflects the growing trend in medicine toward treating vascular disease as an entity, whether heart-related (coronary artery disease) or in the peripheral circulation (legs, kidney, etc.) -- many patients who have vascular disease in one area often have it elsewhere. According to Dr. James Burke, director, cardiac catheterization laboratories and interventional cardiology at Temple University Hospital in Philadelphia, "With our patients as our top priority, we chose Toshiba's Infinix DP-i/FD2 because it was clear that the technology would enable us to improve our diagnosis and treatment capabilities.... We can diagnose and treat all of the cardiac and vascular problems in our patients without compromising either area. This is the future of comprehensive cardiovascular care."

May 25, 2006
Making Patient Safety the Centerpiece of Medical Liability Reform
(source: Hillary Rodham Clinton, and Barack Obama, New England Journal of Medicine)
Important enough for the New England Journal of Medicine to make the full text version available for free, this article discusses the area of liability and malpractice lawsuits in the context of patient safety. Here is an important quote:

"Studies show that the most important factor in people's decisions to file lawsuits is not negligence, but ineffective communication between patients and providers. Malpractice suits often result when an unexpected adverse outcome is met with a lack of empathy from physicians and a perceived or actual withholding of essential information."

We could not agree more with Senators Clinton and Obama. All you need to do is read the various postings on our Patient Forum about adverse events to see how some physicians' "lack of empathy" or the "witholding of essential information" upsets patients and their families. All medical procedures have risks -- anyone who watches a "doctor show" on TV understands this. What hospitals and physicians need to do is clearly explain these risks to the patient. If patients fully and honestly understand the potential complications of any medical intervention, and are able to weigh those against the positive outcomes that the procedure may afford, then both patient and physician are on the same "side" and everyone is pulling in the same direction for the desired result.

May 23, 2006
Toshiba Installs 300th Vantage 1.5T MRI System
(source: Toshiba America Medical Systems)
Toshiba's advantage in this field is its patented Pianissimo™ technology, which reduces by almost 90% the acoustic noise, identified as the most significant cause of patient anxiety. Reduction of the noise often eliminates the need for anti-anxiety medication or sedation during routine scans. In addition, Toshiba’s SPEEDER parallel imaging technology allows clinicians to perform exams in a single breath hold, reducing motion artifacts and increasing image quality. In this company press release radiologist John Mathis from the Center for Advanced Imaging in Roanoke, Virgina, where the 300th Vantage was installed, states, “We typically conduct about 4,500 MRI scans a year, and anxiety caused by system noise is a significant issue for many of our patients. In fact, we receive countless referrals because we offer the latest in MRI technology with improved patient comfort.”
related stories:
Magnetic Resonance Imaging and Angiography (MRI / MRA) -- Angioplasty.Org

May 23, 2006
Campbell Rogers, M.D., International Expert in Interventional Cardiology and Vascular Conditions, Named Chief Technology Officer of Cordis Corporation
(source: Cordis Corporation)
Boston-based Brigham & Women's Hospital's cardiology department is now batting three-for-three. Last fall Dr. Richard Kuntz left to become a Senior VP at Medtronic. Then, earlier this month, Dr. Donald Baim announced he was leaving to become Chief Medical and Scientific Officer for Boston Scientific. Now Dr. Campbell Rogers is poised to become Chief Technology Officer for Cordis, Boston Scientific's arch-rival in the drug-eluting stent world.

May 19, 2006
'Guidant' fading away
(source: Jim McCartney, St. Paul Pioneer Press)
Attendees at this year's Heart Rhythm Society conference may see some Guidant logos around, but not for long, as Boston Scientific re-brands the company it acquired earlier this year. Boston Scientific's current tagline: "We Can and We Will."

May 16, 2006
Recent Clinical Trials Funded by For-Profit Organizations More Likely to Report Positive Findings Than Trials Funded by Not-For-Profits
(source: Journal of the American Medical Association -- JAMA)
A study published in this week's JAMA by Boston researchers from Brigham and Women's Hospital and Harvard looked at 324 recent cardiovascular clinical trials, both drugs and devices. They found, not to anyone's great surprise, that in those clinical trials where there was a financial interest in a positive finding, the results tended to be positive two-thirds of the time. In those trials sponsored by a not-for-profit entity (such as a hospital center) the results tended to be pretty much evenly split.

May 12, 2006
Toshiba's Technology Contributions Featured on Top Morning Talk Show "Live With Regis and Kelly"
(source: Toshiba America Medical Systems)
Toshiba Medical and other Toshiba divisions have donated over $80,000 worth of ultrasound and other equipment to Partners for Healing clinic (PFH) which serves an uninsured community in Tullahoma, Tennessee, as part of “Live with Regis and Kelly’s” 16th annual “Mom’s Dream Come True” Mother's Day special.

May 11, 2006
Desensitization Protocol Overcomes Allergy to Clopidogrel
(source: Society for Cardiovascular Angiography and Interventions -- SCAI)
A careful desensitization protocol can help patients overcome allergic reactions to anti-clotting medication critical to preventing new blockages inside coronary stents, according to a new study being presented at SCAI's annual meeting. Nicholas E. Walker, MD, a cardiology fellow at the University of Iowa, Iowa City, states,“We showed we could successfully and safely desensitize patients who had just recently had a drug-eluting stent placed. That’s a critical population to manage.” (Read more...)

May 11, 2006
Federal Appeals Court Rules in Cardium's Favor Over Boston Scientific and Arch Development on Patents for the Treatment of Heart Disease
(source: Cardium Therapeutics, Inc.)
An court ruling back in March prompted Boston Scientific and Arch Development to an appeal. That appeal has been rejected, reports Cardium Therapeutics, which means that this specific technology for delivering genetic material via catheter to the heart to promote angiogenesis cannot be patented by Boston Scientific and is the exclusive property of Cardium.

May 11, 2006
Boston Scientific Announces Appointment of Donald Baim, M.D.
as Chief Medical and Scientific Officer
(source: Boston Scientific Corporation)
Dr. Baim, currently Senior Physician at the Brigham and Women's Hospital in Boston, will be replacing Dr. Mary E. Russell as of July.

May 9, 2006
Toshiba Achieves Educational Milestone for Unique Physican-to-Physician Speakers Bureau Program
(source: Toshiba America Medical Systems)
The company has now enrolled more than 2,500 cardiologists and radiologists in its education and training programs to help expand the knowledge base among medical professionals regarding the latest diagnostic imaging modalities, and 64-slice CT technology in particular.
related stories:
MultiSlice Computed Tomography (MSCT) -- Angioplasty.Org

May 9, 2006
Safety Risk of Multislice CT Angiogram Compared to Cardiac Catheterization
Two articles in the recent Journal of the American College of Cardiology, published online on April 17, address the debate of how non-invasive MultiSlice Computed Tomography (MSCT) imaging compares to standard angiography (cardiac catheterization) on the issue of safety. Whether or not the radiation dosage of one procedure is higher than another is only one part of the safety equation. (Read more...)

May 8, 2006
Toshiba Ships 600th Aquilion 64-Row Detector System Worldwide
(source: Toshiba America Medical Systems)
In their press release, Toshiba states that this is "a significant milestone for the company’s CT business, which has installed more than 17,000 CT systems in hospitals, imaging centers and medical group practices worldwide, including the Johns Hopkins University School of Medicine, Beth Israel Deaconess Medical Center, Shands at the University of Florida and Cardiovascular Institute of the South (CIS). According to Peter S. Fail, M.D., cardiologist, CIS, growing patient awareness about advances in diagnostic imaging and physician demand for cutting edge imaging technologies has encouraged many healthcare facilities to acquire 64-slice CT systems to remain competitive and better serve patients."

May 8, 2006
Dr. Julio Palmaz, Inventor of Stent Widely Used in Coronary and Peripheral Disease, Inducted Into National Inventors Hall of Fame
(source: Cordis Corporation)
Dr. Julio Palmaz of the University of Texas Health Science Center at San Antonio was inducted into the National Inventor's Hall of Fame on Saturday. Dr. Palmaz was recognized for the invention of the balloon-expandable stent, a revolutionary medical device that he worked on in his garage with materials from Radio Shack et al, inspired by Gruentzig's invention of the angioplasty balloon. Palmaz's stent concept was not confined only to the coronary arteries, but was the basis for the first AAA endograft, among many other devices (Palmaz, worked with and joined fellow Argentinian Juan Parodi, scrubbing in and deploying the stent which he co-invented in the first AAA case done in Buenos Aires -- for more, see our documentary Vascular Pioneers: Evolution of a Specialty). Dr. Palmaz is the holder of numerous important patents in the medical device field.
related stories:
"Origins of the Palmaz-Schatz Stent"
Dr. Richard Schatz, co-inventor of the Palmaz-Schatz stent that revolutionized the treatment of coronary artery disease, discusses Gruentzig's influence on Palmaz and himself -- Angioplasty.Org (RealVideo clip -- RealPlayer required)
Dr. Julio Palmaz, 2006 Inductee profile -- National Inventors Hall of Fame

May 3, 2006
Vasomedical Sells Its 1,000th EECP Therapy System
(source: Vasomedical, Inc.)
The company has announced the sale of its 1,000th EECP® therapy system to St. Francis Hospital, The Heart Center® in Roslyn, New York. "St. Francis Hospital, The Heart Center continues to demonstrate its commitment to providing high-quality services to patients with cardiovascular disease by offering EECP therapy with Vasomedical's state-of-the-art Lumenair™ system," stated Dr. Justine Lachmann, director of the Congestive Heart Failure Program at St. Francis Hospital. This milestone comes at a difficult time for the company. Medicare recently declined to expand the reimbursement indications for EECP therapy, although Vasomedical is hoping to appeal that once their PEECH study is published. As a result the company's stock price has fallen and it has received a delisting notice from NASDAQ.
related stories:
Vasomedical Receives Nasdaq Delisting Notice -- Vasomedical, Inc.
Enhanced External Counterpulsation (EECP) -- Discussion Forum -- Angioplasty.Org

May 2, 2006
Americans Less Healthy than English
(source: Journal of the American Medical Association)
How can this be? The United States spends almost 2 1/2 times more per person on healthcare than the United Kingdom. This study of individuals in late middle age (55-64 years old) was done by London researchers and appears in the May 3 issue of JAMA -- it is sure to raise controversy. The study compared data from both countries and found some interesting facts. 12.5% of Americans suffer from diabetes, double that of the U.K., and high blood pressure is 10% higher in the U.S. Across the board, the British suffer less from diabetes, hypertension, heart disease, heart attack, stroke, lung disease and cancer. As for "vices", smoking was similar is both countries (about 20% in this age group), heavy alcohol consumption was higher in the U.K., obesity much higher in the U.S. As one might expect, lower income groups in both countries were less healthy than those in higher income brackets. But a very interesting statistic -- the differences in health were so great between the two countries that the high income group in the United States had the same health profile as the low income group in Britain. So access to healthcare does not seem to be the cause of this difference, because the wealthiest Americans certainly have access to healthcare. Note also that the study was limited to non-Hispanic whites in both countries to eliminate a bias to health-related issues in the black or Latino populations in both countries.

May 1, 2006
Medtronic Receives FDA Approval for Micro-Driver Stent
(source: Medtronic, Inc.)
The Micro-Driver is a bare metal cobalt alloy system designed specifically to perform in small vessels and tortuous anatomies, and the first bare metal stent for small vessels with an indication for new or untreated vessels (a de novo indication). According to Dr. Michael Ball of St. Vincent Hospital in Indianapolis, "This stent fulfills an essential need that we have in cardiology.... When you do small vessel stenting, you want the stent to be small and you want it to be flexible. That's the whole idea behind Micro-Driver. It conforms well to the anatomy and allows you to take care of more lesions. I think more patients should be able to benefit from this technology." Medtronic states in its press release that even in the drug-eluting stent era, many physicians choose bare metal stents for patient care in small-vessel cases, and the Micro-Driver stent offers them an important treatment option. "

April 27, 2006
Medtronic Receives CE Mark For New Carotid Stent And Filter
(source: Medtronic, Inc.)
The new Medtronic Exponent® RX Self-Expanding Carotid Stent is a tiny metal scaffold that is used to prop open a blocked artery and restore adequate blood flow. While not yet approved for use in the United States, it is part of the Medtronic Carotid Solution, which also includes the Interceptor™ PLUS Carotid Filter System. “Carotid artery disease and stroke affect hundreds of thousands of people each year, and carotid stenting offers patients a less-invasive treatment option when compared to open surgery,” said Sean Salmon, vice president and general manager of Medtronic Vascular’s Coronary and Peripheral businesses. “Products like the Exponent RX carotid stent and the Interceptor PLUS filter are innovatively engineered to provide effective therapy even in challenging and complex anatomies without compromising safety.”

April 24, 2006
Dr. Tom Ferguson, Who Urged Self-Education, Dies at 62
(source: Nadine Brozan, New York Times)
"Tom Ferguson, who spent his life as a physician persuading people to take the reins of their own health care and to use the Internet as a powerful tool in that quest, died on April 14 in Little Rock, Ark.". Dr. Ferguson was a pioneer and foresaw the wave of patient interest in the internet. Besides being the health and medical editor of the famed 60's and 70's Whole Earth Catalog, he also served as senior research fellow at the Pew Internet and American Life Project whose reports we often quote on Angioplasty.Org. regarding patient use of the Internet for health information. The article sums up his philosophy (which we share): "He urged patients to educate themselves and share knowledge with one another, and urged doctors to collaborate with patients rather than command them."

April 24, 2006
Aspirin Dispute Is Fueled by Funds Of Industry Rivals
(source: David Armstrong, Wall Street Journal $$)
Are some heart patients resistant to aspirin? This story (WSJ subscribers only -- sorry) explores the various forces in the pharmaceutical industry that have generated studies and articles both for and against this idea, with one side claiming that the benefits of an inexpensive medication like aspirin are being questioned by doctors who have financial relationships with companies that make the tests for "aspirin resistance" or with pharmaceutical firms that make more expensive antiplatelet medications. Highly-regarded and often controversial Dr. Eric Topol, formerly of the Cleveland Clinic, weighs into the mix as well.

April 20, 2006
Boston Scientific Receives FTC Antitrust Approval for its Combination with Guidant
(source: Boston Scientific Corporation)
The long-awaited and much-anticipated combination of Boston Scientific and Guidant has now cleared its last regulatory hurdle and the deal is set to close tomorrow, Friday, April 21, 2006.

April 11, 2006
Toshiba Names General Manager
(source: Toshiba America Medical Systems, Inc.)
The company has named diagnostic imaging industry veteran, Lawrence Dentice, general manager, senior vice president and an officer of the company. Dentice has been Toshiba’s vice president, sales, since he joined the company in 2002. Former general manager, Edwin Lodgek, has left the company.

April 11, 2006
Boston Scientific Receives European Commission's Antitrust Clearance for Guidant Transaction
(source: Boston Scientific Corporation)
The European Union Commission has given its approval to the combining of Boston Scientific and Guidant, a week earlier than the deadline. This leaves the FTC to approve the deal.

April 10, 2006
Corautus Announces Termination of Patient Enrollment in GENASIS Severe Angina Clinical Trial
(source: Corautus Genetics Inc.)
Based on the recommendation of its independent Data Monitoring Committee (DMC), the company has announced termination of patient enrollment in its GENASIS Phase IIb clinical trial. The trial was suspended on March 14 due to several adverse events which the company stated did not seem to be related to the biologic VEGF-2. The delivery system for the genetic material is manufactured by Boston Scientific with whom Corautus established a strategic alliance and financial relationship in 2003. Given those events, and review of the current data, the DMC saw very little chance for significant efficacy as to the primary endpoint relative to the safety risk signal it saw. Corautus will continue to collect data on patients enrolled to date for six months, at which time the data will be analyzed to determine efficacy. Safety data will be montiored through one year. The company's stock plunged over 67% after the news. What is not clear is the cause of the adverse events; this information will be very important for the entire field of genetic research into treatment of coronary artery disease.

April 10, 2006
Toshiba America Medical Systems Becomes American College of Cardiology Foundation "Imaging Champion"
(source: Toshiba America Medical Systems, Inc.)
Toshiba has announced major support of a series of educational programs presented over the next year by the American College of Cardiology Foundation that will bring together clinical experts in ultrasound, nuclear cardiology, angiography, computed tomography and magnetic resonance imaging to present the current state-of-the-art in imaging and update medical professionals in the field. Of note is the inclusion of Cardiac CT for the first time in several of the programs, indicating the growing interest in this imaging modality.

April 5, 2006
Boston Scientific Signs Agreement Resolving Outstanding Antitrust Issues with FTC Staff
(source: Boston Scientific Corporation)
In this press release the company states that it has entered into an agreement with the staff of the Federal Trade Commission. The agreement contains consent orders and resolves all outstanding antitrust issues with the FTC staff, although the commissioners still need to approve the agreement. Furthermore, the company states that "on or about April 7, it will voluntarily withdraw and re-file its notification under the Hart-Scott-Rodino Antitrust Improvements Act of 1976...to ensure that the FTC Commissioners have adequate time to review the executed consent decree." The H-S-R Act sets a 30-day waiting period after filing. However, Boston Scientific states that they expect to close the transaction by mid-April, about 10 days from today. Currently, Boston Scientific is paying a "late fee" to Guidant shareholders for every day past April 1 that the deal is not closed -- estimated at $4.5 million/day. The stock closed at 21.69 today, down 7% since Friday and below the "collar" inside of which Guidant shareholders get additional shares of Boston stock.

April 5, 2006
Cardium Provides Updated Summary of Generx Clinical Program for Potential Treatment of Coronary Heart Disease
(source: Cardium Therapeutics, Inc.)
The company provides in this press release an updated summary of its clinical development of Generx, a product candidate for the potential treatment of patients with myocardial ischemia and recurrent angina associated with coronary heart disease.

April 4, 2006
Cordis Corporation To Develop Global Cardiac And Vascular Institute
(source: Cordis Corporation)
Cordis Corporation announced today plans to develop a world-class global cardiac and vascular institute that will provide physicians and other health care providers with educational and clinical resources designed to help advance the understanding and treatment of a broad range of cardiac and vascular conditions, including coronary artery disease and stroke. The institute will also enhance knowledge around the management of congestive heart failure, adult cell therapy and advanced cardiac imaging, mapping and ablation.

March 31, 2006
Boston Scientific and Guidant Shareholders Each Approve Combination
(source: Boston Scientific Corporation / Guidant Corporation)
Shareholders of the two companies approved the combination today. Once the European Union and Federal Trade Commissions approve the deal, the two companies will become one.

March 30, 2006
Parma Community Hospital Enhances Patient Care, Optimizes Workflow and Expands Clinical Capabilities with Toshiba's New Infinix-i Series
(source: Toshiba America Medical Systems, Inc.)
The company announces installation of its latest flat panel detector vascular and cardiac imaging system in Parma (Ohio) Community Hospital. A company spokesperson says, "The Infinix CC-i FPD is uniquely designed to meet the select needs of clinicians conducting complex cardiac imaging procedures. In addition to the system’s unparalleled image quality and lower dose, it improves diagnosis and treatment while maintaining patient safety."

March 29, 2006
Cardium Announces Patent Wins Over Boston Scientific and Arch Development Corporation
(source: Cardium Therapeutics, Inc.)
Cardium Therapeutics of San Diego has announced patent decisions which protect and distinguish their method of delivering gene therapy to the heart in order to promote angiogenesis. The company states that the therapy is meant to treat the very small blood vessels in the coronary circulation, vessels too small to balloon or stent open, one reason that patients may continue experiencing angina even after their main coronary arteries are opened up either mechanically or surgically.

March 28, 2006
Borgess Medical Center Enhances Cardiac Capabilities for Advanced Patient Care
(source: Toshiba America Medical Systems, Inc.)
In this press release, the company announces installation of five new catheterization labs in this Kalamazoo Michigan hospital, in addition to the existing Aquilion CT scanner. "According to Tim Fischell, M.D., director of cardiac research at the Borgess Heart Center for Excellence, incorporating diagnostic imaging into the center’s practice has dramatically improved the level of cardiac care they are able to deliver to patients. “CVD continues to be a major problem in our communities, and advances in diagnostic imaging have had a significant impact in diagnosing disease of the heart at its earliest stages and preventing death.” Dr. Fischell is the co-inventor of the BX Velocity stent, which forms the foundation of Cordis' Cypher drug-eluting stent.

March 27, 2006
Medtronic Receives FDA Approval for New AneuRx® AAAdvantage™ Abdominal Aortic Aneurysm Stent Graft System
(source: Medtronic Inc.)
Medtronic has achieved approval for its next-generation, improved AAA stent graft for repairing abdominal aortic aneurysms. Approximately 1.2 million people in the United States have an AAA condition. Only about 15 percent are ever diagnosed and less than half of those are ever treated. The danger of an AAA is that the bulging of the arterial wall in the aorta, the largest artery in the body, will lead to rupture, which is fatal in most cases. The standard surgical treatment for repairing this kind of aneurysm is being replaced in certain patients by an endovascular approach where, much like in coronary angioplasty, a catheter with a special stent is inserted through the femoral artery in the groin, and threaded up into the aorta, where a balloon expands the stent graft and is then withdrawn. The first endovascular AAA repair done in the U.S. was in the early 90's (the story of that procedure, invented by Dr. Juan Parodi of Argentina, can be seen in Chapter Four of our video "Vascular Pioneers" -- RealPlayer required, or buy the DVD). and done in the U.S. by Dr. Frank Veith and Dr. Michael Marin along with Parodi at Montefiore Hospital in New York).

March 27, 2006
European Union Delays Decision On Boston Scientific Buy Of Guidant
(source: Dow Jones Newswires)
The EU had originally said it would make its decision by March 31 on whether or not to approve Boston Scientific's purchase of Guidant. The company stated in a press release late last week that the EU decision might be delayed due to certain confidential commitments made to the Commission to resolve anti-trust issues, but that the decision would not be delayed past April 13 and might be made prior to then. However, the EU Commission today stated that that the new deadline is April 18 and, according to Reuters, has said "the investigation was no longer following its simplified procedure." Last week the Wall Street Journal reported that the five-day delay was due to the long Easter weekend holiday as it is celebrated in Europe. Part of the offer to Guidant shareholders was that Boston Scientific would pay an additional fee/share for every day past March 31. This comes to about $4.5 million/day.
related stories:
EU sets new deadline for Boston/Guidant probe -- Reuters
European Holiday May Cause Small Boston Sci/Guidant Delay -- Wall Street Journal ($$)
Boston Scientific Makes Antitrust Commitments To European Commission -- Boston Scientific Corp. (Mar 23)

March 20, 2006
Institutional Shareholder Services Recommends That Shareholders of Boston Scientific and Guidant Approve Combination
(source: Boston Scientific Corporation)
Shareholders of Guidant and Boston Scientific are scheduled to vote on Friday, March 31 whether to approve the purchase of Guidant by Boston. In this press release, Boston Scientific states that ISS, a "leading U.S. independent proxy advisory firm" has recommended that shareholder vote yes.

March 16, 2006
American Heart Association Statement: Patient Guidance Based on Results of the CHARISMA Trial
(source: American Heart Association)
Dangers of Stopping Clopidogrel (Plavix®) for Patients with Stents and Certain Other Conditions
(source: American College of Cardiology)
In a signficant display of patient e-Powerment, the reaction among patients to the very misleading news coverage of the CHARISMA trial presented at the ACC last Sunday was so explosive that both the AHA and ACC have now seen fit to issue a guidance to patients, saying precisely what we at Angioplasty.Org warned about three days earlier: Stent Patients! Don't Stop Taking Your Plavix and Aspirin without consulting with your cardiologist! As we predicted in our editorial blog entry, cardiologists have been fielding questions all week about whether or not patients should be stopping their Plavix and aspirin regimen. As reflected in the AHA & ACC guidances (actually the ACC calls it a "Public Health Alert") and the AP article below, doctors are saying "don't stop"!
related stories:
Doctors Urge Not to Stop Taking Plavix -- Associated Press
Plavix and Aspirin: Don't Stop Taking Your Meds -- "Voice in The Ear": The Stent Blog

March 15, 2006
FDA Clears Innovative Cardiac Navigation Technology
and
NOGA® Cardiac Navigation System Helps Researchers Deliver Stem Cells to the Heart
(source: Cordis Corporation)
A novel navigation system for 3-D imaging inside the coronary anatomy was approved today by the FDA, and also figures into an experimental stem cell research project to help patients with weak heart who are not candidates for surgery or stenting.

March 14, 2006
256 Multislice CT Angiography One Beat Whole Heart Scan: First Clinical Data at ACC
(source: American College of Cardiology)
Developed in Japan by Toshiba Medical, this experimental CT multislice scanner was able to image the entire heart in a single heartbeat in 1.5 seconds.

March 14, 2006
Corautus Genetics Inc. Announces Developments in Clinical Trial and Public Offering
(source: Corautus Genetics Inc.)
...and the developments they announced aren't positive ones. Corautus has been conducting the GENASIS clinical trial of its VEGF-2 biologic, in conjunction with Boston Scientific and using Boston's Stiletto™ catheter -- the idea is to deliver cells to the heart to improve the circulation through VEGF (vascular endothelial growth factor) as a treatment for severe angina. Three patients recently reported serious adverse events of pericardial effusion which, they stress, does not seem related to the biologic. Boston Scientific requested that Corautus voluntarily suspend the trial while a short review into what the problem might be takes place. Additionally, in light of this development, the company and its underwriters agreed to cancel its upcoming public offering of stock.
related stories:
Corautus halts chest pain trial, stock falls -- Reuters
Corautus Halts Chest Pain Drug Trial -- Associated Press
Angiogenesis -- Angioplasty.Org

March 13-14, 2006
Intensive Statin Therapy May Partially Reverse Plaque Build-up in Arteries
and
Many High Risk Patients Do Not Receive Cholesterol-Lowering Therapies
(source: American College of Cardiology)
The two press releases above from the American College of Cardiology meeting in Atlanta tell a story. The first discusses the ASTEROID trial, presented by Dr. Steve Nissen of the Cleveland Clinic (also President-Elect of the ACC). In this study, his team looked at a group of 500+ patients. Nissen used intravascular ultrasound (IVUS), an imaging technology that actually views the coronary artery from the inside. IVUS allows the most precise measurement of the diameter of the artery, including the thickness of layers of plaque. The patients were studied at the beginning at ASTEROID, then received 40 mg daily of the statin drug rosuvastatin (Crestor®, manufactured by AstraZeneca). 24 months later, the patients were restudied. Their LDL (so-called bad cholesterol) had gone down 53% and their HDL (good) rose almost 15%. But news was generated by the fact that upon IVUS measurement, not only had the progression of coronary artery disease been slowed down -- it was actually reversed. The plaque was reduced between 7-9%. Dr. Nissen has stated that this shows very low LDL levels can reduce plaque -- whether this can actually reduce heart attacks or mortality will need to be determined by a further study. But ASTEROID certainly represents a significant piece of data in the fight against heart disease.

The second press article's headline speaks for itself -- especially ironic in light of the ASTEROID study. Although, like all drugs, statins have some side-effects, it has been known for some time that statins are of benefit to patients at high risk for heart disease. The ASTEROID results, that statins can reverse plaque build-up, are just the most dramatic and recent example of these benefits. So the study results of 142,000 patients who were classified "at risk" is even more troubling: the majority of these patients were not prescribed statin therapy during the first year after diagnosis. States Richard H. Chapman, Ph.D., of ValueMedics Research and lead author of the study, "Statins are the standard of care for this group of patients, and they should be prescribed along with antihypertensive therapy. Failing to do so may restrict patients’ access to potentially life-saving treatment." The conclusion is unfortunately also not new. A year ago, Angioplasty.Org reported on a study out of Stanford by Dr. Jun Ma which came to the same conclusion.

A Google News search found 63 articles about the ASTEROID study, but only one reprinted press release about the second study. Angioplasty.Org will soon be posting an exclusive interview with Dr. Ma of Stanford. Register for our newsletter to be informed when it is online.

March 13, 2006
Stent Patients -- Don't Stop Taking Your Meds: Media Reports About CHARISMA Confuse Patients:
(source: "Voice in the Ear" Stent Blog)
Many headlines and news reports are warning that taking Plavix and aspirin together could be a dangerous combination. These results apply to patients who have no symptoms of arterial disease, but is a very misleading warning for angioplasty/stent patients. Read why in our Editor's Blog.
related stories:
Results of CHARISMA Study -- Press Release -- Bristol-Myers Squibb; sanofi-aventis
Plavix and Aspirin Dosage After Stent -- Angioplasty.Org Forum
CHARISMA: No benefit of long-term clopidogrel in stable disease -- theheart.org (subscription required)

March 12, 2006
Angiomax® (bivalirudin) Monotherapy Superior to Heparins Plus GP IIb/IIIa Combination for Net Clinical Outcome in ACUITY Trial
(source: The Medicines Company)
One of the problems cardiologists have in treating patients who are on their way to the cath lab for either a diagnostic angiogram, or possible an angioplasty/stent placement, is the use of anti-thrombin drugs, blood thinners, etc. It is necessary to administer these medications to ensure a safe interventional procedure -- one where blood clots don't form. But these drugs also tend to cause bleeding, both internally and also at the femoral access point (hematomas, etc.). The ACUITY study, led by Dr. Gregg Stone, has found that a different drug, one that is less likely to cause bleeding, actually performs better than the currently used protocol of Heparin combined with GP IIb/IIIa inhibitors. The drug is Angiomax, or bivalirudin, and it was tested by itself (montherapy) and in combination with the Heparin and GP IIb/IIIa inhibitors. Monotherapy showed superior results, while Angiomax combined with Heparin and GP IIb/IIIA inhibitors was about the same as the Heparin and GP IIb/IIIA therapy alone. Dr. Stone states, "Previous ACS trials have added drug on top of drug to achieve better efficacy, sacrificing safety along the way. The ACUITY trial showed that Angiomax alone is as effective as more complicated dual drug regimens, and results in significantly less bleeding, which means improved outcomes for patients."
related stories:
Angiomax better than other blood thinners-study -- Deena Beasley, Reuters
Medicines Shares Up on Angiomax Study -- Associated Press

March 10, 2006
Initial Results of PROGRESS–AMS Study Confirm Safety and Feasibility of Absorbable Metal Stent Technology in Human Coronary Vessels
(source: Biotronik AG)
Biotronik announces the results of a safety and feasibility trial for its absorbable stent. No cardiac deaths, myocardial infarctions, or stent thromboses were observed. And while the restenosis rate that is not yet "in line with clinical standards", information was gained to fine-tune the degradation process so future trials will hopefully show good restenosis results. Most importantly, the stent was shown to have completely disappeared (using IVUS imaging). Angioplasty pioneer Professor Raimund Erbel, who is the principal investigator in this trial, stated, “The AMS is not just another stent. It represents a revolutionary leap forward in vascular intervention treatment. The AMS provides the necessary short term scaffolding needed to support the vessel during the healing process and is then absorbed, avoiding the long-term mechanical stress of current permanent stent technologies.”

March 7, 2006
KLAS Survey Ranks Toshiba's Aquilion 64-Slice CT System Top Among Leading Medical Imaging Technology Vendors
(source: Toshiba America Medical Systems, Inc.)
The survey included more than 300 healthcare professionals, including imaging directors and managers, C-level executives and physicians on survey categories, including service; ability to deliver product; upgrade path; scanner reliability; end- user presentation; cost and value; technology and architecture; post-processing capabilities; and PACS (picture archiving and communication systems) integration. In addition to Toshiba’s top distinction in overall vendor ratings, the survey revealed that Toshiba scored highest in four categories, including cost and value, technology and architecture, post processing capabilities, and integration into existing PACS solutions.

March 7, 2006
Baxter Commences First-Of-Its-Kind, Phase II Adult Stem Cell Trial in U.S. In Patients With Severe Coronary Artery Disease
(source: Baxter Healthcare Corporation)
This second phase follows a smaller Phase I in which safety of the treatment was demonstrated. In this treatment, patients' own stem cells are reinjected into areas of their heart with critically poor circulation. Only 24 patients were treated, but 16 reported feeling better and having increased exercise capability. Douglas Losordo, M.D., chief of cardiovascular research at Caritas St. Elizabeth's Medical Center in Boston, will be the lead investigator of this second phase. He states, "This trial is the culmination of nine years of research suggesting the potency of CD34+ cells for treating heart disease.... We are delighted that we are on the threshold of the next important phase of testing for this unique autologous stem cell therapy.”

March 5, 2006
A 64-slice heart X-ray, sans catheter, is catching on quickly at Sequoia Hospital
(source: Sam Whiting, San Francisco Chronicle)
This feature, about a community hospital in Redwood City, discusses the benefits of the new 64-slice CT scan technology.

March 4, 2006
Shop and compare hospital care
(source: Bob Moos, Dallas Morning News)
This report from the Dallas Morning News shows how healthcare consumers on the internet are using websites to give hospitals a checkup and make decisions on where to go. From the article: " One of the most popular Web sites is Medicare's, which shows how well 4,200 hospitals follow generally accepted guidelines for treating heart attacks, heart failure and pneumonia and preventing surgical infections."
related site:
Hospital Compare -- Centers for Medicare and Medicaid Services (U.S. Dept. of Health & Human Services)

March 2, 2006
Boston Scientific and Guidant Proposed Merger Registration Statement Declared Effective
(source: Boston Scientific Corporation)
In this company press release, Boston Scientific states that the merger agreement has been accepted as "effective" by the U.S. Securities and Exchange Commission (SEC) and that they expect to close the week of April 3, pending review and approval from the FTC and the European Union

February 14, 2006
WomenHeart and the Society for Women’s Health Research Unveil The 10 Q Report
(source: Society for Women's Health Research)
WomenHeart and SWHR surveyed experts in the cardiovascular field and asked them to identify the top ten unanswered research questions. They cover effectiveness of risk assessment and diagnostic tools, the differences in risk and in effectiveness of therapies for men and women, and the need for improved understanding of cardiovascular disease in women. Two of the questions noted are: (1) Why do women receive significantly fewer referrals for advanced diagnostic testing and treatments for heart disease than men, and how can the referral rate for women be increased? and, (2) Why are women age 50 and younger more likely to die following a heart attack than men of the same age?
related stories:
The Complete 10 Q Report -- Society for Women's Health Research

February 14, 2006
CT Scanner reveals hidden threats
(source: San Jose Mercury News)
Story about a 62-year-old California man who volunteered for a test of a new 64-slice CT scanner at Kaiser Permanente. Although he had no history, indications or symptoms of heart disease, the scan revealed extensive blockage in one of his coronary arteries. The blockage was addressed later with a stent.
related stories:
Image Makers -- The Promise of Cardiac CT Angiography -- "Voice in The Ear": The Stent Blog

February 7, 2006
Boston Scientific Announces Results for Year and Fourth Quarter Ended December 31, 2005
(source: Boston Scientific Corporation)
The company announced financial results from the last quarter and the full year. While profits were up, sales of its Taxus stent were down in the last quarter -- 12% worldwide and 21% in the U.S. The company also stated that it expected to complete its acquisition of Guidant by the end of March, pending regulatory approval.
related stories:
Boston Scientific Net Rises Despite Drop in Stent Sales -- Wall Street Journal $$
Boston Scientific Profit Up, Sales Slide -- Mark Jewell, Associated Press

February 3, 2006
Statement of Boston Scientific CEO Jim Tobin on FDA Meeting
(source: Boston Scientific Corporation)
Boston Scientific CEO Jim Tobin met with the F.D.A. today in an attempt to resolve issues surfaced by the very stern warning letter sent last week which, among other things, froze future approvals of the company's devices. Shortly before 4:00pm, the company issued this short statement. The good news for the company is that the FDA is not going to take further actions and promises to monitor and meet with company officials in a timely manner. The company stated it is committed to resolving the issues on an "aggressive timeline", however, what that timeline might be was not discussed, nor was the lifting of restrictions on new approvals. These will most likely be hot topics to be discussed in detail during next Tuesday's earnings conference call.
related stories:
Device Maker Moves to Appease the F.D.A. -- Barnaby J. Feder, New York Times
Boston Scientific's CEO meeting with FDA today about quality problems -- Avram Goldstein, Bloomberg
Left to One's Own Devices: Adverse Event Reporting -- "Voice in The Ear": The Stent Blog
Boston Scientific holders await comment after FDA talk -- Reuters
Tracking of medical devices taxes FDA -- Star Tribune (Minneapolis)
FDA Statement Regarding Boston Scientific Corporation -- U.S. Food and Drug Administration

February 1, 2006
A Gender Difference In Heart Disease
(source: Rob Stein, Washington Post)
A report on the National Institute of Health's WISE (Women's Ischemia Syndrome Evaluation) study, which found that the disease process of atherosclerosis may manifest itself differently in some women. The article states: "Instead of developing obvious blockages in the arteries supplying blood to the heart, these women accumulate plaque more evenly inside the major arteries and in smaller blood vessels, the researchers found. In other cases, their arteries fail to expand properly or go into spasm, often at times of physical or emotional stress."
related stories:
Gender Differences in the Management and Clinical Outcome of Stable Angina -- Circulation, American Heart Assoc.
The American Heart Association's journal is making this article in the current issue available for free -- it is a European study showing a significant difference in the way women with stable angina, "the most prevalent manifestation of coronary artery disease". are diagnosed and treated when compared to men. The study states, "Women with confirmed coronary disease were less likely to be revascularized [opening up the blocked artery, ed.] than their male counterparts and were twice as likely to suffer death or nonfatal myocardial infarction during the 1-year follow-up period". [Note: the full study is in PDF form; an abstract can be found here.)
Women Are Said to Face Hidden Heart Disease Risk -- Denise Grady, New York Times

January 28, 2006
Boston Scientific Shares Tumble, May Devalue Deal
(source: Wall Street Journal $$)
Echoing what has been wafting over the financial markets all day Friday, the Wall Street Journal reports on how the negative fallout from the FDA warning may affect the Boston Scientific - Guidant acquisition, as BSC's stock price goes lower and lower.
related stories:
Left to One's Own Devices: Adverse Event Reporting -- "Voice in The Ear": The Stent Blog
Boston Scientific's Slippery Slope -- Amy Barrett, BusinessWeek (Feb 1)

January 27, 2006
Corporate Warning Letter to Boston Scientific
(source: U.S. Food & Drug Administration)
The FDA delivered a strongly-worded warning letter to Boston Scientific about its inaction in resolving "serious deficiencies" that were found during previous inspections. In fact, the word "serious" is used 15 times throughout the letter. There are a number of issues addressed, covering a number of Boston Scientific's facilities and products, including the major facility in Maple Grove, where the Taxus stent is produced. The thrust of the letter is that these issues have not been resolved and the FDA is requesting an immediate meeting with senior management, not factory executives, because the agency sees the problem as a corporate-wide failure. Several of the problems have to do with the company failing to file a number of adverse reports to the MDR database in a timely manner. The warning letter states that the FDA could take action without further notice, such as seizing product inventory, obtaining a court injunction against marketing the product, etc. The letter also states that no product approvals will be made until these deficiencies are resolved. The letter is strongly worded because, as the FDA indicates, these issues were surfaced months ago and the matters have not been satisfactorily resolved. The letter was issued the day that Boston Scientific and Guidant penned their acquisition agreement, although not made publicly available until late yesterday, and analysts are mixed over the implications of this news. Jan Wald, a health care analyst at A.G. Edwards stated to the Pioneer Press, "This could put a scare into investors, who could force the stock price down — and that could end up unraveling the (Guidant) deal." According to the Boston Globe, Paul LaViolette, COO and other executives will be meeting on February 3 to discuss the warning letter and they believe they will resolve the issues, although full resolution will depend on changes being made and new inspections, a process that will take months and could possibly delay approval of Boston Scientific's much-anticipated 2nd generation drug-eluting stent, the Liberte. Boston's stock closed down over 6.5% today.
related stories:
Boston Scientific Announces Two Communications From FDA -- Boston Scientific Corporation
FDA warns Boston Scientific over broad problems -- Reuters
FDA Criticizes Boston Scientific Over Quality-Control Deficiencies -- Wall Street Journal $$
F.D.A. Warns Device Maker Over Safety -- New York Times
FDA issues Boston Scientific stern quality-control warning -- Boston Globe
Boston Scientific told to fix plant flaws -- Twin Cities Pioneer Press

January 25, 2006
Boston Scientific and Guidant Announce Signing of Merger Agreement Valued at $27 Billion
(source: Boston Scientific Corporation / Guidant)
Guidant has accepted Boston Scientific's higher bid, rejected Johnson & Johnson's year-long pursuit, and entered into an agreement for $27 billion.

January 25, 2006
Deadline Passes Without J&J Raising Bid
(source: Associated Press)
The midnight deadline passed with no word from Johnson & Johnson on a counter-bid for Guidant, so Guidant's Board must decide by the close of business on Wednesday whether to accept Boston Scientific's significantly higher bid, which is likely. Speculation will now be turned towards what company Johnson & Johnson may look to acquire. Of course, as the New York Times article points out, Johnson & Johnson could announce a new bid earlier on Wednesday even though the deadline has passed, just to draw this drama out even more.
related stories:
Timeline of Guidant Acquisition -- "Voice in The Ear": The Stent Blog
J.&J. Passes on Raising Guidant Bid -- New York Times

January 24, 2006
Toshiba and Cardiovascular Institute of the South Establish Cardiovascular CT Education Partnership
(source: Toshiba America Medical Systems, Inc.)
As multislice CT angiography becomes more widespread, regional centers of excellence are springing up -- hospitals or imaging centers where physicians can go to attend training. This press release announces that Toshiba has teamed up with CIS in south Louisiana to provide training in CT angiography.

January 23, 2006
Boston Scientific Announces Excellent Results in Study of Patients with Renal Artery Disease
(source: Boston Scientific Corporation)
The company announced the results of its Renaissance Study at the International Symposium on Endovascular Therapy (ISET) in Miami Beach. Cardiologist Dr. Krishna Rocha-Singh of Prairie Cardiovascular Heart Institute in Springfield, IL was the study's principal investigator. He presented data with show the restenosis rate in the renal (kidney) arteries was halved through the use of the Express® SD Renal stent (balloon angioplasty rates are around 40% -- the stent reduced it to 21.3). Boston Scientific plans to use the data to apply for marketing approval from the FDA.

January 17, 2006
Guidant Concludes Boston Scientific Offer is Superior
(source: Guidant Corporation)
Minutes before the 5:00pm deadline for Guidant's Board to declare Boston Scientific's newly increased offer "superior", it has done so, setting in motion a five-day period for Johnson & Johnson to reply with a new bid, or give up the acquisition it has worked a year on.
related stories:
Johnson & Johnson Statement Regarding Guidant Corporation Acquisition -- Johnson & Johnson
Disputing Guidant's conclusion that Boston Scientific's offer is superior, Johnson & Johnson calls the offer "a highly dilutive and leveraged transaction based on extremely aggressive business projections" and does not believe the offer will provide shareholders with $80 of value. The press release also states that Johnson & Johnson will consider its alternatives under the existing agreement.
Guidant board deems Boston Scientific bid superior -- Reuters
Guidant calls Boston offer 'superior' -- MarketWatch
Guidant Backs $27 Billion Boston Scientific Bid Over J&J Offer -- Bloomberg News
Timeline of Guidant Acquisition -- "Voice in The Ear": The Stent Blog

January 17, 2006
Guidant drama revives St. Jude takeover talk
(source: Reuters)
Has someone been reading our Editor's blog?
related stories:
"You've got to know when to hold 'em, know when to fold 'em" -- "Voice in The Ear": The Stent Blog (Jan 15)
In summarizing the events of the past week's bidding war, "Voice in the Ear" posited why St. Jude may be a potential partner for Boston Scientific, if J&J were to win the Guidant bid

January 17, 2006
Guidant seeks new offer of $77/shr from J&J
(source: Reuters)
Reuters is reporting at 3:00pm that Guidant is looking for J&J to offer $77 per share to counter Boston Scientific's bid of $80 this morning. This is $1 per share more than J&J was willing to pay a year ago (before Guidant's defibrillator problems were made public). Evidently the Guidant Board feels that $3 per share is the differential between the deal going through quickly (which would be the scenario if Johnson & Johnson acquires them, since the government regulatory review has already been approved) and a bit of the unknown if Boston wins out.

January 17, 2006
Boston Scientific Announces Offer to Acquire Guidant at $80 Per Share
(source: Boston Scientific Corporation)
Boston Scientific assumed a position this morning that was described by TheStreet.com as "leaning back for knockout velocity ". The company has raised its bid well beyond what Wall Street analysts said was needed to beat Johnson & Johnson's offer from last Friday -- Boston is now offering $9.00/share more. Guidant's Board has agreed to consider the new offer. They'd better hurry up. Boston Scientific has placed a 5:00pm deadline today for the Board to declare its offer "superior". Boston used this same strategy last week when their Thursday night offer included a 4:00pm Friday deadline. The deadline passed without comment and Guidant and J&J announced a new higher acquisition agreement later that evening. However, Boston's new bid is so much higher that Guidant's Board will have significant difficulty with their shareholders if they do not either accept this offer, or come up with a new substantially higher agreement with J&J. Some of the substantial increase in Boston Scientific's new offer is founded on Abbott's increased participation, higher price for the vascular divisions, larger loan -- and, new to this agreement -- Abbott will buy 4% of Boston Scientific. More news at 5!!
related stories:
Boston Scientific Raises Bid For Guidant to $80 a Share -- Wall Street Journal $$
Boston Scientific hikes Guidant offer again -- Reuters

January 13-14, 2006
Guidant Corporation and Johnson & Johnson Announce New Definitive Acquisition Agreement
(source: Guidant / Johnson & Johnson)
Is it finally over?? This was the week that was. The New York Times calls it "the biggest takeover battle ever in the medical device industry." Guidant has accepted a newer and higher offer from J&J of $71/share after a day of ups and downs. Thursday night Boston Scientific made a new and sweeter offer to Guidant with renewed emphasis on their making concessions so that the FTC would not have any anti-trust issues -- they even offered to pay in effect 6% interest if the deal took longer than March 31 to close. The new offer came with a 4:00pm Friday the 13th deadline. During the day Boston briefly extended the deadline until 6:00pm because, according to reports, Guidant said it was having logistical difficulties getting everyone together for a meeting by 4:00pm. But less than a half-hour later, Boston retracted the two hour extension, again reportedly because it realized that Guidant was using the extra time to renegotiate a better deal with J&J. Which it did. Guidant has announced that it will accept the J&J offer, and the Wall Street Journal reports that there were still anti-trust concerns over the way Boston Scientific was going to divest parts of Guidant's to Abbott (an issue first raised in last Monday' s Editor's Blog). It's not entirely clear what Boston Scientific will now do. They submitted their formal offer to Guidant last week on a Sunday, so anything could happen, even over this weekend.
related stories:
"You've got to know when to hold 'em, know when to fold 'em" -- "Voice in The Ear": The Stent Blog
Guidant accepts a new J&J offer -- Wall Street Journal $$
Johnson & Johnson Pulls Ahead in Takeover Battle for Guidant -- Barnaby J. Feder, New York Times
Guidant accepts new J&J offer of $24.2 billion -- Reuters
Guidant Accepts Increased $24.2B J&J Bid -- Associated Press
Guidant spurns Boston Scientific -- Stephen Heuser, Boston Globe

January 12, 2006
Boston Scientific Improves Offer to Acquire Guidant
(source: Boston Scientific)
Sweet sweeter sweetest. If only we had all bought Guidant stock right after the New York Times ran its series of articles about their defibrillator defect last spring.... As of tonight, Boston Scientific has increased its bid by $1 a share and guaranteed that the deal will be approved by March 31, or "we'll pay the interest!!" And if you order now...well actually, that's the case. Guidant's Board has until 4:00pm Eastern Time tomorrow (Friday) to accept the offer or it will be withdrawn. If Guidant declares the new deal "superior", they will have until January 24 to accept it. The question is, if Guidant doesn't bite, whether Boston Scientific is feeling confident enough to start a proxy fight for votes at the January 31st stockholders meeting. Several large funds have criticized Guidant's Board for not accepting Boston's higher offer. Again, part of the sticking point seems to be the possibility of a longer drawn-out approval time from the Federal Trade Commission regarding conflicts with product lines, etc. and anti-trust issues.
related stories:
Boston Scientific Sweetens Deal for Guidant -- Wall Street Journal $$
Boston Scientific lifts Guidant bid -- Stephen Heuser, Boston Globe
Stakes High for Boston Scientific in Bid -- Associated Press

January 12, 2006
Guidant Accepts Sweeter J&J Deal
(source: Wall Street Journal $$)
On Wednesday evening, the Guidant Board decided to accept a somewhat raised offer from Johnson & Johnson, but Boston Scientific says it's not over till it's over. In a late night press release, Boston states: "Our discussions with Guidant are ongoing. We intend to vigorously pursue this transaction to its completion." There is thought that Boston may up its bid as well. In any case the Board has recommended to the stockholders to approve the J&J offer. The shareholders will meet on January 31 to vote. Not all of them agree with the Board, for example the hedge fund Elliott Associates LP, owner of 3 million Guidant shares, thinks the Boston deal is better. The Wall Street Journal reports that part of Guidant's concern with the Boston Scientific deal was "how Boston Scientific would divest itself of Guidant's stent and catheter businesses." Boston's package included sellling those to Abbott. The WSJ did not elaborate. We wonder if there were concerns about the FTC not approving the sale to Abbott, something our Editor discussed in Monday's blog entry.
related stories:
Boston Scientific Comments on Johnson & Johnson's Amended Agreement to Acquire Guidant -- Boston Scientific
Guidant accepts JJ offer -- Reuters
Guidant Accepts Revised J&J Bid of $23.2B -- Associated Press
Won't You Be My Neighbor? -- "Voice in The Ear": The Stent Blog

January 10, 2006
Guidant's Board to Meet To Discuss Competing Bids
(source: Wall Street Journal $$)
3:00pm -- that's when Guidant's Board is scheduled to meet today to decide between two competing offers for the company: from J&J and Boston Scientific. There are reports (unconfirmed) that J&J met yesterday with Guidant and may have upped their bid to counter Boston's bid which was formalized on Sunday. As of 5:30pm no announcement has been made, but Boston Scientific's stock dropped 4% at triple the normal trading volume. Stay tuned!
related stories:
J&J may raise its bid for Guidant -- Reuters
Johnson Adds a Late Twist to Guidant Bidding -- New York Times

January 10, 2006
Guidant board to meet on takeover offer
(source: Reuters)
Guidant's Board is reportedly meeting today as to whether to accept Boston Scientific's acquisition offer. If it does, J&J would have 5 days to make a new offer.
related stories:
Elliott Associates Believes Guidant Bid by Boston Scientific Superior to Johnson & Johnson Offer -- Elliott Associates
Hedge fund which is a Guidant shareholder offered its opinion today that anything lower than $71/share from J&J would not be in the shareholders' best interest

January 8-10, 2006
Boston Scientific Submits Definitive Offer to Acquire Guidant for $72 Per Share in Cash and Stock
(source: Boston Scientific)
Boston Scientific, after very quickly completing its due diligence, looking over Guidant's books, has formalized its takeover offer which involves seilling off Guidant's endovascular business to Abbott for $4.3 billion to encourage the FTC, which must review the acquisition, that no anti-trust issues will exist. The details were discussed in an analyst conference call. Boston Scientific has added a "collar" to the deal, so that if its stock value falls, the conversion ratio for Guidant shareholders will be upped. Guidant's board now has to decide whether to accept the bid. J&J who made the initial bid and then lowered it, due to Guidant's legal problems from fault ICDs, will have 5 days to rebid. Meanwhile Guidant shareholders will be voting on the J&J bid at the end of January. This is a very complicated and high stakes situation for all companies involved, although Abbott stands to gain no matter which way the decision goes.
related stories:
Boston Scientific formalizes $25 Billion Guidant bid -- Reuters
Boston Scientific looks to Guidant to boost sales -- Reuters
Quick Thoughts on Boston/Guidant Deal -- "Voice in The Ear": The Stent Blog
Boston Scientific Formalizes Bid To Buy Guidant -- Wall Street Journal $$
Boston Scientific Now Says Buying Guidant Would Not Increase Profits Until '09 -- New York Times
Times reporter Barnaby J. Feder reports in depth on some cautions in the Boston Scientific/Guidant merger from the Guidant side that have caused Boston Scientific to extend the period that it may take to make the acquisition profitable.
Boston Scientific Pushes Back Expectations -- Mark Jewell, Associated Press

January 6, 2006
Boston Scientific Expects Imminent Guidant Agreement; CEO to Stay
(source: Mark Jewell, AP Business Writer)
Boston Scientific expects to finalize its offer to buy Guidant by the end of next week. Guidant shareholders are scheduled to vote on the smaller and earlier offer by Johnson & Johnson on January 31. Boston also announced that Jim Tobin would be staying on as CEO and president "for the foreseeable future." There had been speculation that he might be leaving -- in a recent analysts' meeting he had stated that he was continuing to hand over more and more of his responsibilities to COO Paul LaViolette, to free him up to work on other things. Wall Street analysts have said the stability of Tobin remaining should be comforting to Guidant shareholders.
related stories:
Tobin to stay at Boston Scientific -- Stephen Heuser, Boston Globe
Tobin won’t abridge BSX tenure -- Jennifer Heldt Powell, Boston Herald
2nd suitor preparing bid to buy Guidant -- Jeff Swiatek, Indianapolis Star

January 3, 2006
Coronary CT workups save time, money
(source: In-Sung Yoo, Delaware Online)
Is cardiac CT scanning an alternative to cardiac catheterization for screening patients? This article from a local Delaware paper speaks to some physicians about this growing imaging technology, known as MultiSlice Computed Tomography or MSCT.
related stories:
New scan gives doctors better picture of heart -- WBIR-TV, Knoxville TN (December 5, 2005)