Medtronic, Inc. (NYSE: MDT), announced today that the first patients were randomized in SYMPLICITY HTN-4, evaluating the Symplicity™ renal denervation system in patients with moderate uncontrolled hypertension (systolic blood pressure greater than or equal to 140 and less than 160 mm Hg, despite treatment with three or more anti-hypertensive medications of different classes).
St. Jude Medical, Inc. (NYSE:STJ) has received European CE Mark approval for its 25 mm Portico™ Transcatheter Aortic Heart Valve Implantation System. The approval expands the number of patients who can be treated using the Portico heart valve during transcatheter aortic valve replacement (TAVR) procedures. TAVR is an option for patients with symptomatic severe aortic stenosis (a narrowing of the aortic heart valve that obstructs blood flow from the heart). These patients are considered high-risk for conventional open-heart valve replacement surgery.
Mounting a multicenter, randomized, blinded, controlled clinical trial is an expensive proposition. So when device manufacturer St. Jude Medical, Inc. (NYSE:STJ) decided last week to stop its EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN™ Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure, there had to be a good reason. And there was.
Medtronic, Inc. (NYSE: MDT), today announced the first-in-human implant of the world's smallest pacemaker: the Micra™ Transcatheter Pacing System (TPS). The device was implanted in a patient in Linz, Austria as part of the Medtronic global pivotal clinical trial. The Micra TPS is an investigational device worldwide. At one-tenth the size of a conventional pacemaker, and comparable in size to a large vitamin, the Micra TPS is delivered directly into the heart through a catheter inserted in the femoral vein.
Medtronic (NYSE: MDT) has announced that its multi-electrode Symplicity Spyral™ catheter and Symplicity G3™ radio frequency (RF) generator for patients with treatment-resistant hypertension has received both the CE Mark (Conformité Européenne) in Europe and Therapeutic Goods Administration (TGA) listing in Australia.
Volcano Corporation (NASDAQ: VOLC) today announced that its Board of Directors has authorized a $200 million share repurchase program. The Company intends to fund share repurchases with cash on hand. As part of the program, Volcano will enter into a $100 million Accelerated Share Repurchase ("ASR") with J.P. Morgan Securities LLC ("JPMorgan"), as agent for JPMorgan Chase Bank, National Association, London Branch. Under the ASR agreement, Volcano will pay $100 million to JPMorgan and will receive from JPMorgan an initial delivery of 3,557,137 shares of Volcano's common stock.
Chosen for nearly one out of every two endovascular abdominal aortic aneurysm (AAA) repairs worldwide, the Endurant II AAA stent graft system from Medtronic, Inc. (NYSE: MDT) continues to demonstrate long-term durability and consistent outcomes at three years in a real-world setting. The latest data on the market-leading stent graft were presented on Friday at the VEITHsymposium in New York City.
Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for the Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System, the company's next-generation durable polymer drug-eluting stent (DES). The technology is available immediately in the U.S., with the first implantation scheduled to be performed by Martin Leon, M.D., director, Center for Interventional Vascular Therapy at Columbia University Medical Center / New York-Presbyterian Hospital, New York City.
The first device of its kind to undergo clinical evaluation in the United States, the Valiant "Mona LSA" branch thoracic stent graft system from Medtronic, Inc. (NYSE: MDT) has demonstrated proof of concept in a first-in-human study being conducted under the U.S. Food and Drug Administration (FDA)'s "Innovation Pathway" early feasibility pilot program, according to data presented today at the 2013 VEITHsymposium.
Medtronic, Inc. (NYSE: MDT) announced that a German court today ordered the discontinuation, in its entirety, of a prior court ruling that prohibited Medtronic from commercially marketing or selling the CoreValve® System in Germany since August 26, 2013. The Higher Regional Court Karlsruhe explained that, due to the European Patent Office (EPO) preliminary opinion that the Edwards' EP2055266 Spenser patent claims are not valid, it could not assume "with sufficient likelihood" that the Spenser patent is valid.
Volcano Corporation (NASDAQ: VOLC) today announced the commercial release and initial implantations of its innovative Crux® Vena Cava Filter (VCF) in patients at risk for recurrent pulmonary embolism (PE). It is the only filter with a double helical design that self-centers to help prevent filter tilt and offers the Bi-Trieval™ option of retrieval via either the jugular or femoral vein.
This morning the Society for Cardiovascular Angiography and Interventions (SCAI) issued a guidance document for the use of three major intra-coronary diagnostic tools for use in stenting and angioplasty. Published in the society's journal, Catheterization and Cardiovascular Interventions, the document details the best use of intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR) and Optical Coherence Tomography (OCT) as they relate to the diagnosis and optimal placements of stents.
The one-year results from Medtronic's (NYSE: MDT) pivotal U.S. trial for the CoreValve transcatheter aortic valve replacement (TAVR) device were presented recently at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco, and the results in the extremely risky patient cohort were so clearly favorable that the FDA has waived the requirement for the usual expert panel discussion.
At the recent Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco, Boston Scientific's entry into the transaortic valve replacement (TAVR) field was highlighted in a First Report Investigation report of the REPRISE II Trial, studying the Lotus Valve. Dr. Ian Meredith of the Monash Medical Centre in Melbourne, Australia, presented the 30-day results of 120 patients who received this unique repositionable valve.
Medtronic, Inc. (NYSE: MDT) has announced enrollment of its first patient in a new U.S. clinical trial of renal denervation, this one targeted to test the efficacy of this technology in patients with moderate uncontrolled hypertension. The SYMPLICTY HTN-4 clinical trial will be the first randomized, controlled clinical trial ever to investigate renal denervation in patients with moderate uncontrolled hypertension; it is the second renal denervation trial that Medtronic has launched in the United States.
When Fractional Flow Reserve (FFR) has been used as a decision-making tool in the DEFER, FAME and FAME II studies, the use of stenting declined by one-third, saving costs for the healthcare system and significantly improving outcomes for patients. One drawback to FFR, however, is that a vasodilator, such as adenosine, must be given to the patient to measure the blood flow accurately: this increases costs and often causes discomfort for the patient. In the past few years, however, a new measurement has been developed by researchers in London and is being commercialized by Volcano Corporation (NASDAQ: VOLC). Called iFR (Instantaneous wave-Free Ratio) a functional measurement of ischemia in an artery can be performed very quickly and without need for a vasodilating agent.
Two-year results from the largest study to date of intravascular ultrasound (IVUS) use during angioplasty and stent placement were presented at the 25th Annual Transcatheter Cardiovascular Therapeutics meeting in San Francisco last week, and the numbers were pretty clear: IVUS use showed 53% less stent thrombosis, 38% lower rate of myocardial infarction (heart attack) and 34% less incidence of major adverse cardiac events (MACE).
Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today reported results for the third quarter and first nine months of 2013. The company also today announced a strategic reprioritization and reallocation of resources within its distribution, research and development and clinical programs to focus on areas of strong projected growth in FFR (Fractional Flow Reserve), peripheral applications, coronary IVUS (Intravascular Imaging) driven by the ADAPT-DES clinical data and Axsun Medical.
Commentary from the Editor's Blog: A recent New York Times article delves into a topic not often discussed: the fact that some surgeons are more skilled than others. "A Vital Measure: Your Surgeon's Skill" by Dr. Pauline W. Chen is a fascinating look at a taboo topic. Dr. Chen describes an innovative program where a group of expert surgeons judges how skilled a particular colleague is by looking at a close-up videotape of how he or she works with their hands, utilizes equipment, and so on. However, watching procedures on video is nothing new to me, or to any member of the interventional cardiology community.
In the first head-to-head randomized controlled trial of "third-generation" durable-polymer drug-eluting stents for the treatment of coronary artery disease in an "all-comers" patient population, the Resolute Integrity drug-eluting stent (DES) from Medtronic, Inc. (NYSE: MDT) and the Promus Element DES from Boston Scientific Corp. performed similarly on all measures except longitudinal strength, which favored the Medtronic device.
Commentary from the Editor's Blog: On Tuesday morning the Transcatheter Cardiovascular Therapeutics (TCT) 2013 Conference celebrated the "father of angioplasty," Dr. Andreas Roland Gruentzig, with the Career Achievement Award. Gruentzig, who died in 1985, was honored with a very moving tribute, which included a video, remembrances from his colleagues, and by the presence of his wife and two daughters, who were flown in from Zurich and Berlin by the TCT to receive the award on his behalf.
According to findings from several studies presented at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, patients with coronary artery disease who received an Endeavor or Resolute drug-eluting stent from Medtronic, Inc. (NYSE: MDT) and subsequently interrupted their dual antiplatelet therapy (DAPT) earlier than current guidelines recommend experienced no increased risk of stent thrombosis at one year or more of follow up. Both devices elute the drug zotarolimus to reduce the risk of restenosis.
Following the first U.S. data presented on the Medtronic CoreValve® System in patients treated via the transfemoral approach, Medtronic, Inc. (NYSE: MDT) today announced the positive results of patients treated via alternative access routes as part of the same Extreme Risk Study within the CoreValve U.S. Pivotal Trial. Presented at Transcatheter Cardiovascular Therapeutics (TCT) Conference, the first-of-its-kind observational analysis found that the novel self-expanding valve provided life-saving and quality of life benefits to patients treated via the subclavian and direct aortic ("non-iliofemoral") access routes despite the higher risk nature of the patient population.
Medtronic, Inc. (NYSE: MDT) presented three-year data from SYMPLICITY HTN-2, the first and longest-running randomized, controlled clinical trial of renal denervation, which continue to demonstrate results consistent with data reported previously at six, 12 and 24-months of follow-up. The data were presented for the first time during an oral abstract session on Tuesday, October 29, 2013 at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Symposium taking place this week in San Francisco.
Volcano Corporation (NASDAQ: VOLC) today announced several significant clinical data presentations and other activities related to its physiology and Intravascular Ultrasound (IVUS) technologies at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, being held in San Francisco from October 27 to November 1. The data include final results from the ADVISE II (ADenosine Vasodilator Independent Stenosis Evaluation) Registry, which will be presented in a Late-Breaking Clinical Trials session on October 30.
This week the Society for Cardiovascular Angiography and Interventions (SCAI) issued an important "best practices" document, addressing the transradial approach in which diagnostic angiography and stents are guided to the coronary arteries via the radial artery in the wrist. The transradial approach, although used far more frequently in Europe, Japan and India, has increased 13-fold in the U.S. over the past five years. The SCAI document covers a wide range of topics: for example, how to transition a hospital to the radial approach, how to avoid blocked blood flow in the radial artery (radial artery occlusion or RAO), and how to reduce radiation exposure.
Abbott (NYSE: ABT) announced today the the U.S. Food and Drug Administration has approved its MitraClip device for use in "patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery." Seven months ago the MitraClip was the topic of intense discussion by the FDA panel tasked with judging its safety, efficacy, and risk-benefit ratio. The panel voted 8-0 in favor of safety, a tie-breaking 5-4 against efficacy, but 5-3 for a favorable risk-benefit ratio.
The technical challenges with TAVI procedures that must be surmounted are many. Today, Medtronic announced that several of these limitations are being addressed in an initial study of 60 patients who will be treated with a new iteration of the CoreValve. The CoreValve® Evolut™ R Recapturable System has been designed to allow recapturing and repositioning of the valve during deployment, better conformability to an irregular annulus, and a delivery system that utilizes a smaller sheath to reduce the profile needed to access the patient vessel.
I read yesterday morning that I was now a party to "The Great Coronary Angioplasty Debate." (Note to self: don't look at Twitter before Sunday brunch.) This all started a week ago, when Dr. Nortin Hadler posted an op-ed piece on The Health Care Blog, titled "The End of the Era of Coronary Angioplasty." He opined that angioplasty was unnecessary in the setting of a major heart attack (a.k.a. STEMI) and might even worsen outcomes. His title and thesis was so over-the-top (intentionally so, I'm sure) that I felt obliged to pen a response to his very anti-stent article.
Today Medtronic, Inc. (NYSE: MDT) announced the product launch of its latest thrombus aspiration catheter, the Export Advance, which recently received a 510k clearance from the U.S. Food and Drug Administration. The Export Advance received the CE Mark this past May. Over one million patients have been treated using Export aspiration catheters. This latest model features a stylet, pre-loaded with a core wire that runs through the middle of the shaft to provide more support during delivery to increase deliverability and kink resistance.
Volcano Corporation (Nasdaq: VOLC) today announced it will report its operating results for the third quarter of fiscal 2013 on Monday, November 4. The company will hold a conference call to discuss its financial results and operating activities open to all interested parties at 2 p.m., Pacific Standard Time (5 p.m., Eastern Standard Time) Monday, November 4, hosted by Scott Huennekens, president and chief executive officer, and John Dahldorf, chief financial officer.
Five years ago, interventional cardiologists in Japan decided that to make the transradial approach even easier, the equipment needed to be downsized, literally — and the Slender Club Japan was started, initiated by Dr. Fuminobu Yoshimachi. Interventionalists got together for workshops and meetings throughout Japan to demonstrate new innovations and techniques, "slender" techniques with miniaturized equipment. Now Dr. Ferdinand Kiemeneij, father of the trasradial approach, is bringing the Slender Club to Europe and has announced a very special kick-off meeting for the Slender Club Europe on February 14, 2014.
Medtronic, Inc. (NYSE: MDT) has announced a number of updates and presentations that will be made at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Francisco, the largest gathering of interventional cardiologists and related healthcare professionals in the U.S. This year marks the 25th annual TCT. Perhaps the most anticipated data for Medtronic will be from the first U.S.-based CoreValve trials of a self-expanding transcatheter heart valve in patients suffering from severe aortic stenosis.
How does a physician treat a heart attack where the blood flow to the heart muscle is suddenly cut off by a blocked artery? In the most severe cases, the ST segments on the ECG are elevated, signalling that a major part of the heart muscle is at risk. It's called a STEMI (ST-Elevated Myocardial Infarction). And, if you subscribe to the concept that the heart and circulation are like the plumbing in your house, like Dr. Charles Dotter did (he invented the concept of angioplasty and, in his offbeat humorous way, he used the graphic to the left as his logo), then you would assume there are two major ways to treat the problem: use Drano to dissolve the blockage or use a mechanical roto-rooter to clear it out.
My first thought upon seeing this Op-Ed piece posted today on The Health Care Blog was that it was yet another article railing against the overuse of stents in patients with stable angina.
But, as I continued to read the article, I saw that Dr. Hadler's premise is that angioplasty may not be necessary even in the severe cases of STEMI, and that clot-busting drugs could achieve the same outcomes at less expense and less risk for the patient. He spends most of his article discussing the recent STREAM study.
Cook Medical's Zilver® PTX® drug-eluting stent for use in the treatment of peripheral artery disease shows excellent outcomes at four years when used in the superficial femoral artery (SFA). After four years the Zilver PTX showed a primary patency of 75% compared to only 57.9% for the BMS, representing a 41% reduction in restenosis at four-years.
Obviously, with the Federal government in shut down mode, a situation precipitated by the House of Representatives' demand to delay the implementation of the already-implemented Affordable Care Act (a.k.a. Obamacare), no new device approvals will be forthcoming today, or any other day, until the U.S. Government gets an infusion of start-up capital (puns intended).
For the next three days, scores of interventional cardiologists will be gathering in New York City for the Second Annual AIM-RADIAL Master Class where they will hear talks, engage in roundtable discussions, watch live case demonstrations, and be thoroughly immersed in advanced state-of-the-art techniques, the latest data and the most current evidence-based medicine regarding all aspects of the transradial technique for diagnostic angiography and percutaneous interventions.
Marking what Medtronic, Inc. (NYSE: MDT) is calling a major advance for the interventional treatment of peripheral artery disease, the FDA has expanded the indications for Medtronic's Complete SE vascular stent to treat atherosclerosis in the superficial femoral artery (SFA) and proximal popliteal artery (PPA), the vessels which carry blood through the upper legs.
I was alerted via Twitter today that the Macy's department store, formerly Foley's, in Houston, Texas was demolished yesterday. The building has significance for the world of medicine. Foley's is where Michael DeBakey purchased a bit of Dacron fabric, which he fashioned into an arterial graft to repair an aortic aneurysm, an achievement which gave birth to the wide spectrum of medical devices we have today.
Specialists at Stony Brook University Heart Institute in Stony Brook, New York, have begun enrollment in a clinical trial investigating the first cardiovascular stent that opens a heart vessel the same way as metallic stents but then dissolves away naturally. The new stent could prove to have benefits over standard metallic drug-eluting stents in relation to vessel blood flow and how much natural motion returns to the vessel after it dissolves.
This October, Open Heart, a new online only peer-reviewed cardiology journal will launch its initial website, with publication of its first round of articles targeted for early 2014. Announced at the recent European Society of Cardiology meeting in Amsterdam, Open Heart is a sister publication to Heart and the newest addition to the BMJ family, which is publishing it in partnership with the British Cardiovascular Society.
The Cardiovascular Research Foundation (CRF) has announced the late breaking trials and first report investigations that will be presented at next month's Transcatheter Cardiovascular Therapeutics (TCT) 2013 scientific symposium. TCT, the world's premier educational meeting specializing in interventional cardiovascular medicine, will take place October 28 - November 1, 2013 at The Moscone Center in San Francisco, California.
The final three-year data from Medtronic's (NYSE: MDT) Symplicity HTN-1 renal denervation trial were presented at the recent European Society of Cardiology (ESC) Congress in Amsterdam. Symplicity HTN-1 is the first and longest-running trial for this novel blood pressure treatment for patients with uncontrolled high blood pressure. The results were significant: half of the patients achieved a systolic blood pressure of less than 140 mm Hg despite having a mean systolic blood pressure of 170 mm Hg when the trial started.
Six and twelve month data from 1,158 patients analyzed in the the Global SYMPLICITY Registry were announced by Medtronic, Inc. (NYSE: MDT) today at the European Society of Cardiology (ESC) Congress, being held in Amsterdam. The data show safety and efficacy of the Symplicity™ Renal Denervation System that are consistent with outcomes being seen in the Symplicity HTN-2 randomized controlled trial.
Volcano Corporation (Nasdaq: VOLC) is rapidly expanding its offerings for peripheral artery disease, today announcing an agreement with Medtronic (NYSE: MDT) to acquire Medtronic's Pioneer Plus product line of diagnostic ultrasound transducer and subcutaneous catheters.
Medtronic, Inc. (NYSE: MDT) announced on Thursday that it had submitted its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon (DEB), to be used in the treatment of peripheral artery disease (PAD) in the superficial femoral artery. Medtronic reports that with submission of this data, it is on track to gain FDA approval in two years, which would make it the first drug-eluting balloon available in the U.S. for use in the treatment of peripheral disease.
When news reports about former President George W. Bush receiving a coronary stent were published this past Tuesday, the blogosphere and twitterverse erupted. Much of the ensuing commentary and critique was directed at the circumstances and diagnostic pathway that led to Bush's angioplasty. Reacting to the many comments critiquing the decision to put a stent in Bush's artery, Scott Huennekens, the President and CEO of Volcano Corporation, one of two manufacturers of FFR catheters (St. Jude is the other), put out the following statement on Friday.
Cook Medical of Bloomington, Indiana is once again shipping its Zilver PTX drug-eluting stent for use in treating peripheral artery disease. The company reports that the FDA has approved their fix of the catheter tip separation problem that prompted Cook's voluntary recall in April, followed by an FDA Class I recall a month later.
Volcano Corporation (NASDAQ: VOLC) said today that it will be participating in the Canaccord Genuity 33rd Annual Growth Conference on Thursday, August 15. The presentation by Scott Huennekens, president and chief executive officer, will begin at 8:00 a.m., Eastern Daylight Time (5:00 a.m., Pacific Daylight Time).
Former President George W. Bush received an angioplasty and stent this morning at Texas Health Presbyterian Hospital Dallas. The stent was recommended by Bush's doctors to open a blockage in one of his coronary arteries, found yesterday during what was described by Bush spokesman Freddy Ford as his annual physical exam at the Cooper Clinic in Dallas. But was this procedure necessary?
Volcano Corporation (Nasdaq: VOLC) today reported results for the second quarter and first six months of 2013. For the quarter ended June 30, 2013, Volcano reported revenues of $101.3 million, an increase of six percent on a reported basis versus the same period a year ago and 12 percent on a constant currency basis after adjusting for a negative impact of approximately $5.5 million from foreign currency. Medical segment revenues increased more than seven percent and more than 13 percent on a reported and constant currency basis, respectively.
Commentary from the Editor's Blog: For years I have been getting Google News Alerts for any articles containing the keywords angioplasty, stent, etc. But recently I've been seeing more and more stories from Toronto NewsFix, and they don't add up.
Volcano Corporation (Nasdaq: VOLC) today announced it will report its operating results for the second quarter of fiscal 2013 on Monday, August 5. The company will hold a conference call to discuss its financial results and operating activities open to all interested parties at 2 p.m., Pacific Daylight Time (5 p.m., Eastern Daylight Time), Monday, August 5, hosted by CEO and president, Scott Huennekens, and CFO, John Dahldorf.
Today a court in Mannheim Germany found that Medtronic's CoreValve® System infringes a patent owned by Edwards Lifesciences (the Spenser patent). Medtronic, Inc. (NYSE: MDT) respectfully disagrees with the court's decision and intends to appeal. In a separate European Patent Office proceeding, Medtronic and others have challenged the validity of the Spenser patent. Ultimately, Medtronic believes that Edwards' patent claims will be found to be invalid, which will negate today's ruling of patent infringement.
Abbott (NYSE: ABT) announced this morning that the Japanese ministry has approved the company's newest generation XIENCE Xpedition™ Everolimus Eluting Coronary Stent System for use in treating coronary artery disease. This approval represents an important step forward for Abbott -- Japan is a major market for stents and Abbott's stent sales have dropped this past year, especially in the U.S.
In our interview with Dr. Caputo, he discusses how the landscape of transradial has changed in the past 5 years from introductory "evangelical" didactic lectures to mentorship and adoption by hospitals for economic benefit and improved patient care, from basically a physician-centered to an institutional-centered concern.
Commentary from the Editor: The whole marketing message of "our stent beats your stent" has just become so Early 21st Century. Times have changed: Cordis is no longer in the coronary stent business and Boston Scientific is trading at 15% of what it was back then. And devices have changed: they have all gotten much better. These days, most drug-eluting stents studies show outcomes that are pretty close.
Indiana-based medical device company Cook Medical is celebrating its golden anniversary as a company today. It was 50 years ago in 1963 that angioplasty pioneer William ("Bill") Alfred Cook started Cook Medical in the spare bedroom of his Bloomington, Indiana apartment. Today the Cook Group consists of 42 companies employing more than 11,000 people at 15 manfacturing sites in the United States, Europe, Asia and Latin America.
On the occasion of the 20th anniversary of transradial intervention (TRI), Angioplasty.Org talked with Dr. Ferdinand Kiemeneij, "the father of transradial intervention" and interventional cardiologist at OLVG, Amsterdam. In this two-part interview, we cover a wide range of topics regarding TRI, from the history of the procedure to Dr. Kiemeneij's vision of the future of TRI and what needs to happen for its ultimate worldwide acceptance as the default approach for catheter-based intervention.
Two year results from the TWENTE clinical trial, which compared two second-generation drug-eluting stents, are reported in the current issue of the Journal of the American College of Cardiology. At one-year, the two stents, Medtronic's Resolute zotarolimus-eluting stent and Abbott's Xience V everolimus-eluting stent, had similar clinical outcomes in 1,391 "real-world" patients, randomized 1:1 to either stent.
An Editor's perspective piece about the transradial (wrist) approach to angioplasty and stents appears in the current issue of "Circulation: Cardiovascular Interventions." Penned by Associate Editor J. Dawn Abbott, MD, the article, titled "Diffusion of Innovations and Adoption of Transradial Intervention," explores why it has taken so long (and continues to) for the transradial approach to be adopted widely in the U.S., given that the evidence from clinical trials has been clear, and that the economic and patient comfort benefits are evident.
At last month's EuroPCR meeting, the one-year results of a novel new stent showed impressive results. Although this was a small pilot first-in-human study for safety and efficacy, enrolling only 30 patients, at twelve months there were no cases of either clinically-driven target lesion revascularization or stent thrombosis. And, as measured by OCT, more than 98% of the stent struts were covered by endothelium.
Guest post from Dr. Frank J. Criado, Editor in Chief of Vascular Disease Management, examines a recent meta-analysis of DES vs BMS for therapy below the knee. The study was authored by Dr. George A. Antoniou et al from the Manchester Royal Infirmary in the UK and apeared in a recent issue of the Journal of Endovascular Therapy.
Yesterday's edition of USA Today carried an article by Peter Eisler titled, "Six common surgeries often done unnecessarily" — and, you guessed it, angioplasty and stents were at the top of the list. I was a bit taken aback because I was not aware of any new study, federal or independent, that concluded stents were being vastly over-used. And it turns out that there wasn't one.
We estimate that by the end of 2013, TRI will account for 20% of all PCIs. That's one in five. Pretty impressive. When was the last time a medical procedure that is less expensive, more comfortable for patients and has fewer complications, grew this quickly? You can read more in our article, "Wrist Angioplasty Sees Unprecedented Growth in U.S.," which reports on an important study which was published in this week's Circulation. Or you can do something about it and become part of this revolution by getting into the training loop.
In tomorrow's issue of Circulation, a landmark analysis of almost 3 million coronary interventions performed in the U.S. from 2007 to 2012 concludes that utilization of the transradial approach, in which balloons and stents are delivered to the heart via the radial artery in the wrist instead of the femoral artery in the groin, has increased 13-fold in the past five years.
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval to begin the EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN™ Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure.
Medtronic, Inc. (NYSE: MDT) announced today that its IN.PACT Admiral drug-eluting balloon clinical program had reached the enrollment needed to support submission to the FDA for approval to use this novel device in the treatment of peripheral disease, specifically blockages in the superficial femoral artery. Although the IN.PACT family of drug-eluting balloons (DEB) have been available in Europe for over four years, no drug-eluting balloons have been approved for use in the United States.
The Endurant AAA stent graft system from Medtronic, Inc. (NYSE: MDT) continues to distinguish itself, with new data on the market-leading device for the endovascular repair of abdominal aortic aneurysms demonstrating durable clinical performance through three years of patient follow-up. The data show 100 percent freedom from aneurysm-related mortality, 0 percent post-implant aneurysm rupture, 0 percent stent graft migration and 0 percent conversion to open repair for the 107 patients followed to three years.
Medtronic today announced FDA approval for the newest additions to its endovascular aortic aneurysm repair product line: the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the Sentrant Introducer Sheath. The company also announced that these devices will be on exhibit at the Medtronic booth during the Society for Vascular Surgery's "Vascular Annual Meeting 2013," which starts today May 30 and runs through the weekend at the Moscone Center in in San Francisco.
Abbott (NYSE: ABT) announced this week that it has gained European CE Mark approval for its 48mm XIENCE Xpedition everolimus-eluting coronary stent, making it the longest coronary stent currently available. Prior to this approval, the longest drug-eluting stent (DES) was 38mm, available from several manufacturers.
Pretty amazing! Last week a 104-year-old man from Noida, India became reportedly the oldest patient ever to receive an angioplasty and stent. As reported in the Hindustan Times, Hari Singh was admitted to Metro Hospital and Heart Institute on May 16 with chest pain. Angiography showed two 100% totally occluded arteries and a 90% blockage near the origin of his Left Anterior Descending (LAD) artery.
Today the U.S. Food and Drug Administration issued a Class I recall of the Zilver PTX Drug-Eluting Peripheral Stent. One month ago, Cook Medical, the device manufacturer, issued its own voluntary recall. It was not immediately clear as to why the FDA has now issued its own recall.
One-year data from an Italian multicenter randomized controlled trial of the IN.PACT Falcon drug-eluting balloon from Medtronic, Inc. (NYSE: MDT) demonstrate positive and durable clinical results with the novel angioplasty device in the treatment of stenotic de novo lesions in small coronary arteries. The new data come from the BELLO (Balloon Elution and Late Loss Optimization) study, which enrolled 182 patients across 15 hospitals in Italy to evaluate the safety and effectiveness of two medical devices: Medtronic's IN.PACT Falcon drug-eluting balloon (DEB) and the Taxus drug-eluting stent (DES) from Boston Scientific Corp.
Medtronic, Inc. (NYSE: MDT) today announced it has received Conformité Européenne (CE) Mark for valve-in-valve (VIV) procedures using the CoreValve® and CoreValve® Evolut(TM) transcatheter aortic valve implantation (TAVI) systems in degenerated bioprosthetic surgical aortic valves. This is the first ever regulatory approval for VIV procedures, which provide a minimally invasive treatment option for patients whose surgical aortic valves have degenerated, and who are at extreme or high risk for surgery and would otherwise go untreated.
This week Medtronic, Inc. (NYSE: MDT) announced that the most recent addition to its portfolio of aspiration catheters, the Export Advance, has received the CE Mark and will soon be launched in Europe and other markets. To date, over one million patients have been treated using Export aspiration catheters.
Addressing one of the most common clinical challenges in the treatment of complex coronary artery disease, three separate analyses on the program for EuroPCR this week show how strongly the Resolute drug-eluting stent from Medtronic, Inc. (NYSE: MDT) performs in coronary bifurcation lesions over the long term.
Volcano Corporation (NASDAQ: VOLC) today announced that it will demonstrate the Verrata™ Pressure Guide Wire and the iFR® (Instant Wave-Free Ratio™) modality throughout the week during the EuroPCR 2013 Congress in Paris, France. These two interventional tools are intended to help physicians guide more procedures and make more decisions based on actual heart function, rather than relying on the angiogram alone.
Volcano Corporation (NASDAQ: VOLC) today announced it will highlight its efforts to expand research and innovation surrounding its physiology technologies, including its Fractional Flow Reserve (FFR) and iFR® (Instant Wave-Free Ratio™) technologies, via various clinical and educational presentations and events at EuroPCR 2013 in Paris.
Interventional cardiologists…listen up!! Stent and angioplasty procedures in the United States are now done through the wrist 15-20% of the time. This is a big change! And, according to Dr. Sanjit Jolly of McMaster University in Hamilton, Canada, in three to five years, half of all U.S. procedures will be done through the wrist. Get that interventional cardiologists? HALF!
Volcano Corporation (Nasdaq: VOLC) today reported results for the first quarter of 2013. For the quarter ended March 31, 2013, Volcano reported revenues of $93.2 million, an increase of three percent on a reported basis versus the same period a year ago and eight percent on a constant currency basis after adjusting for a five percent negative impact from foreign currency. Medical segment revenues increased four percent and nine percent on a reported and constant currency basis, respectively.
Vascular specialists at Carolinas HealthCare System in Charlotte, N.C., and the Cleveland Clinic in Ohio recently performed the initial implants of a novel stent graft system from Medtronic, Inc. (NYSE: MDT) as part of a U.S. Food and Drug Administration (FDA) initiative designed to encourage more early-stage clinical research on new medical devices in the United States. These implants were among the first to be performed under this FDA early feasibility pilot program, which includes a total of nine medical devices from different companies.
Commentary from the Editor's Blog: The paradox of low occurrence of complications yet high impact on the individual has been around for a long time, but I always remember the comments of Andreas Gruentzig, the inventor of coronary angioplasty, when I interviewed him in 1985. Gruentzig, ever conscious of the patient, discussed the question of complications and had very specific thoughts about the physician's role. See the video.
The TCT (Transcatheter Cardiovascular Therapeutics) annual meeting is, according to its organizers, the world's largest and most important conference in interventional cardiovascular medicine. And this year marks the 25th Anniversary of the TCT (note: the entire field of interventional cardiology is only 36 years of age). This year also marks Dr. Ajay Kirtane's role as an official Co-Director of the TCT, in recognition of his contributions and dedication to the meeting.
Up to 10 percent of patients with high blood pressure are resistant to treatment, which puts them at increased risk of cardiovascular events, including heart attacks. Clinical trials show that catheter-based renal denervation reduces blood pressure in patients who do not respond to conventional drug therapy. Use of the technique is increasing in Europe and worldwide and several National Societies have published guidance on which patients with hypertension should receive treatment. The European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) decided it was time for a European view and have developed an expert consensus document on catheter-based renal denervation. April 22, 2013
Volcano Corporation (Nasdaq: VOLC) today announced it will report its operating results for the 1st quarter of fiscal 2013 on Thurs, May 2. The company will hold a conference call to discuss its financial results and operating activities open to all interested parties at 2 p.m., PDT (5 p.m., EDT), Thursday, May 2, hosted by Scott Huennekens, president and chief executive officer, and John Dahldorf, chief financial officer.
The American College of Cardiology Board of Trustees today announced that Shalom "Shal" Jacobovitz has been selected as the college's chief executive officer. "Shal has a track record that demonstrates he is the right person to lead a strong organization like the ACC and to take it to the next level at a time when health care is undergoing massive changes," said ACC President John Gordon Harold, MD, MACC.
This week the Journal of the American College of Cardiology: Cardiovascular Interventions published an article detailing the two-year pooled analysis of outcomes from Medtronic's international RESOLUTE Global Clinical Program of over 5,100 patients: how this data showed positive results for the interventional treatment of patients with diabetes, and how these outcomes led the FDA to approve the Resolute Integrity for use in diabetic patients.
Today the FDA Circulatory System Devices Panel spent many hours listening to testimony from Abbott Vascular, surgeons, cardiologists and patients about the MitraClip Clip Delivery System in order to decide in a final vote whether to recommend that the FDA approve the device for indication in patients too sick or not eligible for surgical mitral valve replacement, but healthy enough so that this device would provide significant benefit.
Today's FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee heard testimony from Abbott Vascular, surgeons, cardiologists and patients about the MitraClip Clip Delivery System and what its recommendations to the FDA would be regarding approval of the device. The votes were 8-0 on safety, 5-4 against efficacy, and 5-3 for a favorable risk-benefit ratio.
Volcano Corporation (NASDAQ: VOLC) is best known for its angioplasty and stent optimization technologies of intravascular ultrasound (IVUS) imaging catheters, virtual histology (VH) software and its line of fractional flow reserve (FFR) functional measurement devices. Today the company announced the launch of an entirely new microcatheter product line, starting with the Valet® Microcatheter.
Important news for stent patients and cardiologists alike: data from a new analysis of Medtronic's (NYSE: MDT) RESOLUTE drug-eluting stent program show very low occurrence of stent thrombosis when dual antiplatelet therapy (DAPT) is interrupted or discontinued after one month.
Medtronic, Inc. (NYSE: MDT) has announced two landmarks in its quest to bring the first renal denervation system to market in the United States. The Symplicity™ Renal Denervation System is currently available in Europe, but no renal denervation system is yet available in the U.S. In fact Medtronic is the only company currently running a pivotal clinical trial, aimed at FDA approval.
Volcano Corporation (Nasdaq: VOLC) said today that it will be participating in two upcoming investor conferences. On Tuesday, March 12, the company will participate in the Barclays Global Healthcare Conference 2013, and on Monday, March 18, the company will participate in the 25th Annual Roth Conference.
Medtronic, Inc. (NYSE: MDT) today announced that its Resolute Integrity drug-eluting stent has received CE Mark approval for a labeling update to read, "...patients who interrupt or discontinue DAPT medication one month or more after stent implantation are considered at low risk and showed no increased risk for stent thrombosis." The Conformité Européenne decision was based on an analysis of 5,000 patients enrolled in the RESOLUTE Clinical Program, which at one year showed no stent thrombosis in the 907 patients who discontinued dual antiplatelet therapy (DAPT) after one month.
For interventional cardiologists in the Northeast, the next few months offer two important transradial training opportunities…on both sides of the Hudson River: in New Jersey, on April 20, will be the Mid-Atlantic Radial Symposium (MARS2013); and in New York, on June 28-29, will be the NYCTRAC, organized by the Cardiovascular Research Foundation.
Today Medtronic (NYSE: MDT) announced that its Engager™ Transcatheter Aortic Valve Implantation (TAVI) System with transapical delivery catheter has received the European CE Mark. This new system, which demonstrated positive clinical outcomes in its European Pivotal Trial, will offer a new option for patients with severe aortic stenosis who are at high risk for surgical aortic valve replacement.
Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, will hold its 2013 Analyst Day on Thursday, March 7, at the NASDAQ MarketSite in New York City. A webcast of the event will begin at 10 a.m., Eastern Standard Time (7 a.m., Pacific Standard Time) and conclude at approximately 2 p.m., Eastern Standard Time (11 a.m., Pacific Standard Time).
Medtronic Inc. (NYSE: MDT) announced this morning that its Resolute Integrity zotarolimus-eluting stent was approved by the FDA in two additional longer lengths, 34mm and 38mm. As the only drug-eluting stent (DES) currently approved by the FDA specifically for use in diabetic patients, the availability of stent lengths that can be used in long lesions, which are more common in diabetics, solidifies the positioning of the Resolute Integrity as a primary choice for the treatment of coronary artery disease in these patients.
Volcano Corporation (NASDAQ: VOLC) today reported its fourth quarter revenue which was $102.5 million, up 10% over the same period last year. Leading the increased revenue were disposables in Volcano's fractional flow reserve business, which were up 45% on an annual basis. While the adoption of FFR has lagged behind the clinical data, Volcano's reported 45% increase in revenue definitely points to increasing use of this technology to optimize stent placement and decision-making.
Medtronic, Inc. (NYSE: MDT) today announced financial results for the third quarter of fiscal year 2013, which ended January 25, 2013. One of fastest growing segments of this $4 billion company was the coronary division which grew 19% overall. Fueled by sales of its Resolute Integrity Zotarolimus-eluting stent, approved last year in the U.S. and Japan, drug-eluting stent quarterly revenue was up 42% to $274 million.
February 18, 2013 No More Financial Assistance for Plavix from Bristol-Myers But Are Generics Really the Same?
Bristol-Myers Squibb (NYSE: BMY) is no longer offering its $37-a-month Plavix® Co-Pay Discount Card. And some patients are not happy about this. Additionally, according to the company's web site for "Patient Assistance Programs," the company is no longer making this life-saving drug available to patients who cannot afford it. This, of course, has something to do with the fact that brand-name Plavix has gone off patent and generic versions have been available since May 2012. But are the generic versions of clopidogrel really the same?
Renal denervation, a catheter-based procedure designed to lower blood pressure, has been the subject of much interest to the interventional community over the past couple of years. Although high blood pressure puts one in three adults worldwide at risk of heart attack, stroke and kidney failure, the renal denervation studies that have been conducted to date have looked only at reducing blood pressure rather than the overall impact on major cardiac events. St. Jude's (NYSE:STJ) announcement today of the EnligHTNment trial is the first that will look at "hard end points" such as heart attack, stroke and mortality.
Medtronic, Inc. (NYSE: MDT), today announced FDA approval and U.S. launch of its Advisa DR MRI™ SureScan® pacing system. The Advisa MRI system is Medtronic's second-generation MR-Conditional pacemaker and is the first system to combine the most advanced pacing technology with proven MRI access.
Medtronic, Inc. (NYSE: MDT) announced today it will report financial results for the third quarter of its fiscal year 2013 on Tuesday, February 19, 2013. A news release will be issued at approximately 6:15 a.m. Central Time and will be available at www.medtronic.com/newsroom. The earnings news release will include summary financial information for Medtronic's third quarter, which ended January 25, 2013. Medtronic will host a webcast at 7 a.m. Central Time to discuss financial results for its third quarter.
Volcano Corporation (Nasdaq: VOLC) today announced it will report its operating results for the fourth quarter of fiscal 2012 on Thursday, February 21. The company will hold a conference call to discuss its financial results and operating activities open to all interested parties at 2 p.m., Pacific Standard Time (5 p.m., Eastern Standard Time), Thursday, February 21.
St. Jude Medical has announced enrollment of the first patient in the EnligHTN II trial, a post-market clinical study that will further evaluate the safety and efficacy of the EnligHTN™ Renal Denervation System in patients with uncontrolled hypertension. This expanded study will enroll 500 patients in 40 centers throughout Europe and Australia with five year follow-up.
CardioKinetix, Inc., a medical device company, based in Menlo Park, California, recently announced the start of a major U.S.-based trial for their Parachute™ Ventricular Partitioning Device, the first catheter-based treatment for heart failure. Implanted in a procedure similar to coronary angioplasty and stents, initial smaller trials for the device have shown positive results at two and three years. As a result of this data, the Parachute currently is approved for use in Europe and carries the CE Mark. The PARACHUTE IV Trial expects to enroll 478 patients in the U.S.
Volcano Corporation (Nasdaq: VOLC) today announced it has a new interactive educational tool to facilitate learning about IVUS-guided interventional procedures with its new Visions® PV .035 Digital IVUS Catheter. The new Aortic IVUS App for iPad, available on the Apple App Store, provides case examples with interactive education on the procedural workflow and image interpretation, and is intended for healthcare professionals involved in endovascular aortic procedures.
This is very big news. Today the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the Acute Cardiovascular Care Association (ACCA) and the Working Group (WG) on Thrombosis of the European Society of Cardiology (ESC) published their joint consensus document on the radial approach to PCI, online ahead of print in EuroIntervention.
Last month Dr. Oz did a segment on transradial angioplasty and featured Dr. Jennifer Tremmel. But while what Dr. Tremmel discussed was certainly of interest to Dr. Oz's lay audience, the story of how she came to practice the transradial approach is most instructive for those interventional cardiologists who are thinking about learning the radial technique.
Expanding its role in the treatment of peripheral artery disease, Medtronic, Inc. (NYSE: MDT) today announced the CE (Conformité Européene) mark and international launch of its Complete SE (self-expanding) vascular stent for use in the lower extremities –– specifically, the superficial femoral arteries (SFA) and proximal popliteal arteries (PPA), which supply blood to the legs. In the U.S., the Complete SE stent is approved by the FDA only for use in the iliac arteries. Its use in lower-extremity arteries in the United States is under review by the FDA.
When I have interviewed Drs. Nico Pijls, Bernard De Bruyne, William Fearon, and Justin Davies, proponents of the modern-day fractional flow reserve (FFR) technology, I asked, "Isn't FFR the modern version of what Andreas Gruentzig was doing with pressure gradients when he first invented coronary angioplasty almost four decades ago?" And the answer was, "Absolutely, yes!"
Medtronic, Inc. (NYSE: MDT), today announced completion of enrollment in IN.PACT SFA II, the U.S. arm of its clinical study for the IN.PACT Admiral drug-eluting balloon as a treatment for peripheral artery disease in the superficial femoral and proximal popliteal arteries (SFA and PPA). Results of IN.PACT SFA II will be combined with those from IN.PACT SFA I, which previously completed enrollment of 150 patients in Europe, to support a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA).
Swedish Medical Center and the Seattle Science Foundation are teaming up once again to provide training in the transradial (or wrist) approach for interventional cardiologists. Titled "The Transradial Approach: A Case-based and Hands-on Training Course," this two-day course runs from March 1-2, 2013.
Check out the first post of 2013 on our new blog. "The Activated Patient." It's titled "Singing On The Table: Be Activated in 2013 with a Non-Resolution" and it's all about what it means to be "activated" — not just for heart patients, but for the rest of us as well.
We spent a long time choosing a name for this blog: the empowered patient, the informed patient, the educated patient, the engaged patient, we tossed around many of the trending terms that signal a more patient-centered attitude toward heart health. But activated stuck because, like that tenor's will to sing, it seems to capture a quality that belongs to the patient and comes from within – not something health professionals do to patients (educate, inform), or permit (empower, engage), but something patients summon up and create for themselves.
Volcano Corporation (Nasdaq: VOLC) said today that it expects total revenues for the fourth quarter of 2012 will be approximately $102.5 million, bringing expected full year 2012 revenues to approximately $381.9 million.
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