December 8, 2004
Sirolimus-Eluting vs Uncoated Stents for Prevention of Restenosis in Small Coronary Arteries - A Randomized Trial
A report from the SES-SMART study, (chief invesigator: Diego Ardissino, MD; Division of Cardiology, Ospedale Maggiore, University of Parma) concludes that "The use of sirolimus-eluting stents to treat atherosclerotic lesions in small coronary arteries reduces restenosis and may also reduce major adverse cardiac events." The study pitted Johnson & Johnson/Cordis' CYPHER stent against its bare-metal BX balloon-mounted stent in small diameter arteries, always considered a difficult and sub-optimal population because of high restenosis rates. The resulting reduction of restenosis from 53.1% to 9.8% with the CYPHER is further evidence that drug-eluting stents may represent a revolution in the treatment of CAD. Further stats showed a reduction in MACE (Major Adverse Cardiac Events) from 31.3% to 9.3%. An accompanying editorial by David R. Holmes, Jr, MD of the Mayo Clinic discusses the encouraging results.
(source: Journal of the American Medical Association)

November 11, 2004
Medtronic Provides Update on Endeavor™ Drug Eluting Coronary Stent Program
Medtronic says that its Endeavor drug-eluting stent is on track for European CE Mark approval in early 2005 and that it is moving forward in the U.S. with its ENDEAVOR IV Clinical Trial. The company plans to present eight and nine-month clinical results from its ENDEAVOR II Clinical Trial at the American College of Cardiology (ACC) annual conference in March 2005. The Medtronic Endeavor Drug Eluting Coronary Stent system combines Medtronic’s Driver™ Coronary Stent, the drug ABT-578 and a PC polymer into a drug eluting stent system designed to reduce restenosis.
(source: Medtronic Inc.)

November 16, 2004
Boston Scientific Announces Strategic Alliance with REVA Medical, Inc.
Boston Scientific has made an investment and exclusive option to purchase arrangement with REVA Medical, Inc. of San Diego -- which is developing a balloon- expandable, bioresorbable drug-eluting stent that combines distinctive geometry and resorbable polymer properties. The REVA stent is designed to perform comparably to metallic drug-eluting stents and then be resorbed by the body once the artery has healed.
(source: Boston Scientific Corporation)

November 1, 2004
Angiotech free to provide exclusive license to Boston Scientific
Company press release states that the antitrust law's waiting period has expired and it is now free to grant an exclusive license to Boston Scientific for use of paclitaxel and other agents on medical devices. Expiration of the period also triggers a $25 million payment to Cook Incorporated.
(source: Angiotech Pharmaceuticals, Inc.)

November 1, 2004
J&J May End Stent Shortcomings With Guidant Buy
Speculation in the financial publication that Johnson & Johnson may be looking at acquiring Guidant, an action that would marry their sirolimus drug coating with Guidant's state-of-the-art stent. More on this as it, and if it, develops.
(source: Forbes)

October 27, 2004
Boston Scientific Announces Start of Enrollment in ARRIVE 2 Drug-Eluting Stent Registry
The company states that it "plans to enroll 5,000 patients at approximately 60 centers in the United States. The program is designed to collect and analyze "real-world" safety and clinical outcomes data from the TAXUS™ Express2™ paclitaxel-eluting coronary stent system in the treatment of patients with coronary artery disease." Different from a clinical trial, which uses very restricted patient groupings to establish whether or not a products is worthy of approval, a registry can document a wider range of information to see how a specific therapy is performing in a number of "patient subsets".
(source: Boston Scientific Corporation)

October 21, 2004
New Stents Tied to Rare Heart Attack Risk
The possibility of stents causing thrombosis, where the blood in the coronary artery clots and causes a heart attack, has been a known complication, which is why patients are prescribed anti-clotting drugs after stent implantation. For bare metal stents, only a month or so of antiplatelet therapy is necessary; aspirin and clopidogrel, or Plavix, are the most commonly used. But the newer drug-eluting stents delay a process known as endothelialization, where cells cover over the stent, as part their prevention of restenosis. That is why patients who have received drug-eluting stents are asked to continue taking antiplatlet medication for up to a year, and often lifelong for aspirin. Now, a study published in The Lancet, has detailed four cases where patients experienced a heart attack from thrombosis of a drug-eluting stent about a year after implantation, and shortly after stopping antiplatelet therapy. While still a rare occurrence, this report emphasizes the need for continued study, the importance of patients continuing antiplatlet therapy and the careful assessment needed by physicians when deciding to stop this therapy.
(source: Ed Edelson, HealthDay)

October 21, 2004
One Stent Maker Thrives; a Rival Gets the Kudos
From the Business Section of the New York Times, this article discusses how Boston Scientific's Taxus stent has captured 70% of the marketplace, yet it claims that there is "growing evidence that while Taxus is easier to insert, Johnson & Johnson's Cypher...may produce better results for most patients." The article posits that, while "...early studies directly comparing the medical results of the two stents have been too small or too flawed in design to produce thoroughly reliable statistics," there are some physicians who favor the Cypher. While the data is still very limited, comparison between products may well become possible when results from the larger scale REALITY trial are announced at the annual American College of Cardiology session in March. The trial is sponsored by Johnson & Johnson and endeavors to determine which of the two currently available stents are better. (The results were to have been announced in two weeks at the American Heart Association meeting, but were delayed by Johnson & Johnson.) To date, a number of large-scale one and two-year studies have been presented at various meetings, for both Taxus and Cypher individually (in these trials, each stent was compared to a control group of bare metal stents, but the two drug-eluting stents were not compared to each other). These studies have shown that both drug-eluting stents work quite well and that neither have radically different results when measured against the older bare metal stents. There is also a controversy among cardiologists as to what data should be used to measure success -- a highly technical discussion that is being discussed at meetings such as the TCT. Stay tuned.
(source: Barnaby J. Feder, New York Times -- free registration required)

October 18, 2004
FDA Public Health Notification: CYPHER™ Stent Not Associated With Higher Sub-Acute Thrombosis
The FDA has studied all the data regarding the concern over the CYPHER and has concluded that it is safe and effective when used correctly and that the rate of sub-acute thromboses in these stents, reported last fall, were within the norm for bare metal stents. Angioplasty.Org's editorial of a year ago, "Unraveling the Cypher", emphasized the same conclusion.
(source: U.S. Food & Drug Administration)

October 14, 2004
FDA Expects No Action on Taxus Stent Recall
The FDA has reviewed the recall and has concluded that the Boston Scientific has fixed the defect and that the stents now on the shelves are safe. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, states, "I am not contemplating any regulatory action...From our point of view, it's pretty much the end of the story."
(source: Mark Jewell, AP Business Writer)

September 30, 2004
Boston Scientific reports revival in sales of stents
Rebounding from three recalls, the company's Taxus stent has recovered its popularity and now has more than 70% of the market.
(source: Laura Johannes, Wall Street Journal -- free registration required)

September 29-October 1, 2004
Boston Scientific Announces Two-Year Follow-Up Data from TAXUS II Clinical Trial
Boston Scientific Announces Two-Year Follow-Up Data from TAXUS IV Clinical Trial
Boston Scientific Announces Results From TAXUS Registries
Boston Scientific Announces 30-Day Safety Data From Its TAXUS V Drug-Eluting Stent Clinical Trial
A "flood" of company press releases that announce various positive results presented at this year's Transcatheter Cardiovascular Therapeutics (TCT) symposium, all regarding the Taxus drug-eluting stent. The results showed that the coated stent was safe and effective -- low reclosure rates even in diabetic patients. One concern over drug-eluting stents has been that they only delay the reclosing of the blood vessels (restenosis). However, the long-term data showed that the benefits of the Taxus actually improved over time, leading Professor Antonio Colombo, M.D., the TAXUS II trial's Principal Investigator, to state, "This data indicates that TAXUS stents may prevent -- rather than merely delay -- in-stent restenosis." The registries in the third article tracked over 7,000 patients worldwide and showed widespread safety of the device. The final Taxus V clinical trial is of great interest because it deals with narrow arteries and complex lesions that need multiple overlapping stents. In an evening symposium, Dr. Gregg Stone speculated whether, if the final Taxus V and VI results were comparable to the early indications, at some point in the future, these minimally invasive procedures might end up replacing most bypass surgery.
(source: Boston Scientific Corporation)

September 30, 2004
Study: Cordis Cypher Stent Effective
Results of a small Korean study released Thursday show Cordis Corp.'s Cypher drug-coated stent outperformed Boston Scientific Corp.'s Taxus Express2 stent in a multicenter study of patients with long lesions (blockages longer than 24mm). The center said the study showed patients with the Cypher stent had a 7.4 percent restenosis rate compared with a 21.3 percent rate for the Taxus stent. These are significantly higher restenosis rates for Taxus stents than have been reported in a number of other studies -- no explanation of this differential was given..
(source: Associated Press)

September 28, 2004
Guidant Reports Positive Six-Month Results from the SPIRIT FIRST Everolimus Eluting Coronary Stent Trial
After an earlier unsuccessful trial of drug-eluting stents, Guidant's new coated stent shows no restenosis at six months and a MACE (Major Adverse Cardiac Events) of 7.7%, which was on par with previous studies. Notable for its use of the immunosuppressant drug Everolimus, developed by Novartis, and its cobalt chromium metal stent (most others are made of stainless steel). Although the trial was very small, only 60 patients, the study's lead investigator, Prof. Patrick W. Serruys, M.D., of the Thoraxcenter, Erasmus University Hospital, Rotterdam, stated, “I believe this highly deliverable cobalt chromium drug eluting stent will be an extremely competitive product when introduced to the marketplace.”
(source: Guidant Corporation)

September 27, 2004
Study: Cypher Stent Comparable to Bypass in Tough Cases
Johnson & Johnson's Cypher drug-eluting stent works about as well as open-heart surgery in patients with multi-vessel coronary disease, according the the ARTS II study, presented at this year's TCT meeting in Washington. The first study ARTS I compared patients who received bare metal stents with those who got open heart bypass surgery. ARTS II added patients with the drug-eluting CYPHER stent. After six months, event-free survival rate for Cypher patients was 93.6%; for those who received bypass surgery, it was 91%; with bare metal stents, down to 80%.
(source: Daniel Rosenberg, Dow Jones News))

September 24, 2004
Angiotech and Cook Restructure License Agreement
"Stent Wars" has taken another shift. Cook has announced that it is exiting from the coronary vascular field; Angiotech is now changing its agreement with Cook (who had distributed a paclitaxel-coated stent in Europe) and is offering Boston Scientific an exclusive use of their proprietary coating (now used in the Boston Scientific's Taxus stent).
(source: Angiotech Pharmaceuticals, Inc.)

September 14, 2004
Johnson & Johnson Delays Stent Study Release
Results of the much-touted comparison REALITY study of Boston Scientific's Taxus stent and Johnson & Johnson's Cypher stent (an independent study sponsored by Johnson & Johnson) have been delayed by the company until the spring of 2005.
(source: Robert Steyer, TheStreet.com)

September 14, 2004
Abbott Vascular Devices Enrolls First Patient in Clinical Trial of the ZOMAXX™ Drug-Eluting Coronary Stent
The company states in this press release that this "milestone demonstrates Abbott's intent to become a key player in the drug-eluting stent arena. For more background on Abbott's position, read "Abbott seeks foothold in high-stakes stent business", an article from Reuters.
(source: Abbott Laboratories / Julie Steenhuysen, Reuters)

September 8, 2004
FDA Completes Galway Inspection; No Observations Reported
The U.S. Food and Drug Administration has now completed inspection of both of Boston Scientific's plants that produced the Taxus and Express2 stent systems and has reported no observations of any problems.
(source: Boston Scientific Corporation)

August 31, 2004
Milestone II Registry Reaffirms Positive Safety Outcomes of TAXUS™ Express2™ Stent System
At the European Society of Cardiology's (ESC) annual meeting in Munich, the company presented 6-month data from the European component of the Registry which reaffirmed the safety and effectiveness of the Taxus stent system, especially in difficult lesions and patients with diabetes.
(source: Boston Scientific Corporation)

August 26, 2004
Boston Scientific Announces Enrollment of First Patient in Clinical Trial for Next-Generation Paclitaxel-Eluting Coronary Stent System
The company has begun clinical trials on its second-generation drug-eluting stent.
(source: Boston Scientific Corporation)

August 19, 2004
FDA Approves Extension of Expiration Date for TAXUS™ Express2™ Paclitaxel-Eluting Stent System to Nine Months
In good news for the company, the FDA has reviewed and accepted data that the drug-eluting system remained stable and well within FDA specifications at nine months -- this allows a longer shelf life for the system.
(source: Boston Scientific Corporation)

August 7, 2004
FDA Seeks More Data From Boston Scientific a Day After Expanded Month-Old Stent Recall
After meeting with Boston Scientific officials in Washington, the FDA's top medical devices regulator, Dr. Daniel Schultz. said he did not immediately see a need to widen the recall beyond the nearly 100,000 Taxus and Express 2 model stents already recalled. "The preliminary indication is that these quality assurance measures are adequate to ensure the safety of the product," he said in a conference call.
(source: Mark Jewell, AP Business Writer)

August 6, 2004
Boston Scientific FDA Meeting Goes Well
The Food and Drug Administration met with Boston Scientific today and stated that the company's quality controls are "adequate" and that its remediation efforts appear to have succeeded in protecting patients. (Note to patients: patients who have received a Taxus stent are not affected by the recall -- the problem was not with the stent, but with the catheter system used to deliver the stent -- Editor, Angioplasty.org)
(source: TheStreet.com staff)

August 6, 2004
Boston Scientific stock still weak amid skepticism
In the past 6 weeks, the company has issued 3 voluntary recalls to remove Taxus stent systems that their new inspection process has identified as holding the potential to cause slow or non-deflation of the balloon which could cause serious problems and complications for the patient during delivery. (For more information, read Angioplasty.org's feature article on the recall.) There have been 95 non-deflation reports out of an estimated 1.1 million stents placed. The company states that a new manufacturing process has eliminated this potential, but physicians and patients are being cautious about the Taxus.
(source: Debra Sherman, Reuters)

August 5, 2004
Boston Scientific Expands Recall of TAXUS Coronary Stent System
The Company today announced that its own ongoing monitoring has revealed the need to expand the July 16th recall nationwide to include approximately 3,000 additional TAXUS stent systems, predominantly in the United States. These stent systems are within the parameters defined in the July 16th action.
(source: Boston Scientific Corporation)

July 30, 2004
Boston Scientific Reports Stent Use: Company Says Half of 20 Hospitals That Halted Use of Stent Are Using Them Again
"Boston Scientific appears to have performed a very detailed root-cause analysis of the problem and has identified the issue," said Jeffrey J. Popma, director of interventional cardiology at Brigham and Women's
(source: Associated Press)

July 22, 2004
Boston Scientific Receives FDA Approval for Clinical Trial of its Liberte™ Paclitaxel-Eluting Coronary Stent System
A new drug-eluting stent is has been going through clinical studies in Europe. Now, in the U.S., this pivotal study, the ATLAS trial, will assess safety and efficacy of the Liberte™ next-generation drug-eluting stent system
(source: Boston Scientific Corporation)

July 20, 2004
Boston Scientific Holds Conference Call With Doctors to Dispel Fears About Heart Stents Recall
Paul LaViolette speaks to the details of the Taxus stent recall in this webcast (free registration required -- if you want details, this hour-long webcast has them). "They're reaching out to doctors, catheterization lab managers and others in hospitals, seeking to reassure them about the safety and efficacy of our stent systems and to answer any questions they have," stated Paul Donovan, Boston Scientific spokesperson.
(source: Mark Jewell, AP Business Writer)

July 17, 2004
Boston Scientific to Recall Additional Coronary Stent Systems
The company announced today that it is expanding its recall of the Taxus stent system, as well as some lots of the Express2 bare metal stent. Problems had occurred in a small number of stents, having to do with the deflation and subsequent withdrawal of the delivery balloon on which the stent is mounted. An earlier recall was limited to two manufacturing lots. Most important for patients is that "...today's action does not affect patients who have already received these stents, because the difficulty is with the delivery system and occurs at the time of insertion, not afterward."
(source: Boston Scientific Corporation)

July 2, 2004
Boston Scientific Recalls 200 TAXUS™ Stent Systems
The company announced today that it is voluntarily recalling nationwide approximately 200 units of its TAXUS™ Express2™ Paclitaxel- Eluting Coronary Stent Systems due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure. The lot numbers are listed in the press release. The Company has notified the U.S. Food and Drug Administration (FDA). FDA has received reports of one death and 16 serious injuries associated with balloon deflation. Since the problem is with the delivery system, the recall does not affect any patients who have received the Taxus stent.
(source: Boston Scientific Corporation)

May 7, 2004
Boston Scientific to modify Taxus -- Action aims to fix complications with stent balloons
Boston Scientific Corp. will modify the way it makes parts of its new Taxus coronary stent system, a spokesman said yesterday, to address medical complications that have cropped up for its hot-selling device.
(source: Ross Kerber, Boston Globe)

May 4, 2004
Boston Scientific Announces Preliminary Information on U.S. TAXUS Sales for April
The Company estimates its share of the U.S. drug-eluting stent market -- as of April 30th -- to be in excess of 70 percent, on a reorder basis.
(source: Boston Scientific Corporation)

April 8, 2004
FDA sends letter to Cordis about Cypher stent; "Patients should not be concerned"
On Friday, Cordis received a warning letter from the FDA regarding Good Manufacturing Practice (GMP) guidelines that were found to be deficient at several plants that manufactured the Cyper stent. What does this mean for patients?
(source: Angioplasty.org)

April 5, 2004
Boston Scientific Announces Preliminary Results Related to First Quarter Sales
The first 18 days of sales in the U.S. went well beyond company estimates, showing that the Taxus stent is being adopted very quickly.
(source: Boston Scientific Corporation)

April 2, 2004
Cordis Cardiology Issues Statement Regarding FDA GMP Warning Letter
Cordis Cardiology reported today that it received a warning letter from the U.S. Food and Drug Administration (FDA) regarding FDA's observations concerning the Good Manufacturing Practice (GMP) regulations, following standard post-approval site inspections completed in 2003, including sites involved in the production of the CYPHER® Sirolimus-eluting Coronary Stent.
(source: Cordis Corporation)

April 1, 2004
European Patent Office Declares Medinol Patent Invalid
In a decision that is final and not appealable, a patent held by Medinol has been ruled invalid, and the injunction against sales of Boston Scientific's Express™ and TAXUS™ stent systems in The Netherlands has been lifted.
(source: Boston Scientific Corporation)

March 31, 2004
Boston Scientific Announces Conclusion of Enrollment in TAXUS V Clinical Trial
"The lesions enrolled in TAXUS V are some of the most challenging we face as interventional cardiologists," said Gregg Stone, M.D., Principal Investigator of TAXUS V. "We are hopeful that the outcomes of TAXUS V in this higher-risk patient population will extend the results from TAXUS IV, broadening the range of patients who may benefit from this breakthrough technology." (For background on drug-eluting stents, read our exclusive interview with Dr. Stone.)
(source: Boston Scientific Corporation)

March 31, 2004
CYPHER® Sirolimus-eluting Coronary Stent Approved for Marketing in Japan
CYPHER® Stent distribution in Japan is expected to begin mid-year, coincident with government approval of reimbursement. Japan is the world's second largest interventional cardiology market with approximately 166,000 angioplasties performed annually, 70% of which involve stent placement.
(source: Cordis Corporation)

March 22, 2004
Boston Scientific Announces Preliminary Information Related to Sales of TAXUS Stent System
The company reports that in the first 10 days that its new coated stent has been on the market, the adoption rate has been around 65%.
(source: Boston Scientific Corporation)

March 8, 2004
Drug-Coated Stents Aid Angioplasties
Another study presented at the ACC showed how drug-eluting stents had a significant effect in reducing restenosis (reblocking) of small vessels, 2mm and narrower. These arteries in the heart historically have been very difficult to treat successfully, but this new study from the University of Parma in Italy, and sponsored by Johnson & Johnson / Cordis, showed that dramatic improvement over bare metal stents.
(source: Daniel Haney, Associated Press)

March 8, 2004
Balloon usually unneeded before stent, study finds (source: Ransdell Pierson, Reuters)
Study Shows CYPHER™ Sirolimus-eluting Coronary Stent Yields Strong Results Without Pre-dilatation (source: Cordis Corporation
A report on the DIRECT study, presented at this year's American College of Cardiology session showed that "direct stenting" with the Cypher drug-eluting stent may be preferable to the standard procedure, currently part of the FDA protocol, where a plain balloon is used first to open up (pre-dilate) the narrowed vessel. In this study, the restenosis rates were slightly lower with direct stenting and the procedure was about 25% shorter. Of interest is the finding that in cases of small vessels and diabetic patients, the difference between the two techniques was even more significant. Also, as reported by theHeart.org, since this study compared more recent patients with those done earlier, it is possible that improved technique in the lab and familiarity with the new drug-eluting stents had some effect. Certainly further study is needed, but these findings may change the way cardiologists perform stent procedures in the future.

March 5, 2004
Boston Sci CEO Says Expect Quick Adoption Of New Stent
A discussion with Chief Executive Jim Tobin about the immediate outlook for the new Taxus stent, approved yesterday by the FDA
(source: Daniel Rosenberg, Dow Jones News)

March 4, 2004
Boston Scientific Announces FDA Approval for its TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System
The much-anticipated FDA approval of the company's drug-eluting stent occurred today. "This approval is a breakthrough event for the treatment of cardiovascular disease in the United States," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "Broad, consistent clinical data and extensive real-world experience have clearly demonstrated that polymer-based delivery of paclitaxel is a safe and effective therapy that dramatically reduces restenosis." For more information, read our special feature about the Taxus stent.
(source: Boston Scientific Corporation)

February 26, 2004
Medtronic Optimistic About Its Drug-Eluting Stent Effort
Medtronic management has said it expects to have a 20% market share worldwide in drug-eluting stents during fiscal 2008.
(source: Daniel Rosenberg, Dow Jones Newswires)

February 25, 2004
Johnson Scrambles to Hold Lead in Heart Stents
A good article containing Interviews with several interventional cardiologists and Wall Street analysts about yesterday's announcement of the Cordis-Guidant alliance, it begins, "With Boston Scientific poised to introduce a drug-coated device to keep coronary arteries open, Johnson & Johnson is scrambling to protect its lead in what is likely to soon be a $3 billion market."
(source: Reed Abelson, New York Times)

February 24, 2004
Stent wars heat up as Guidant, J&J form pact
(source: Julie Steenhuysen, Reuters)
J&J, Guidant Join Forces
(source: Alyce Lomax, The Motley Fool)
Guidant's 'Coup'
(source: Forbes.com)
Guidant Deal With J&J Raises Its Stent Market Profile
(source: Daniel Rosenberg, Dow Jones Newswires)
Several articles about the Guidant-Cordis pact to market the CYPHER stent in light of the much-anticipated of Boston Scientific's TAXUS drug-eluting stent.

February 24, 2004
Guidant Gains Immediate Access to Drug Eluting Stent Market
Cordis Corporation Announces Strategic Alliance with Guidant Corporation to Combat Coronary Artery Disease
A pair of press releases from Guidant and Cordis announcing their alliance to jointly market Cordis' CYPHER stent, currently the only drug-eluting stent approved for use in the U.S. Guidant's stent in in trials and not expected to become available until 2006. This partnering is seen as a strategic move to slow down Boston Scientific whose TAXUS stent is expected to gain U.S. approval very shortly. Read several analyses of this new skirmish in the "Stent Wars" above.
(source: Guidant Corporation / Cordis Corporation)

February 20, 2004
Rival wants a piece of Cypher
Article about the impact that competition in the drug-eluting stent field may have on Cordis, from a newspaper in Florida, Cordis home state
(source: John Dorschner, Miami Herald)

February 20, 2004
Doctors, Hospitals Eagerly Await Boston Sci's Taxus Stent
Article talks to a number of U.S. cardiologists about the choice they may soon have with the anticipated approval of the Taxus drug-eluting stent.
(source: Daniel Rosenberg, Dow Jones Newswires)

February 18, 2004
Enrollment Complete in First Randomized Head-to-Head Trial of Drug-eluting Coronary Stents
Cordis announces completion of patient enrollment in the REALITY trial which will compare their Cypher stent with Boston Scientific's Taxus. Both drug-eluting stents have been shown effective in reducing restenosis -- the Cypher was approved by the FDA last April; the Taxus approval is expected sometime early this year. The stent comparison, results of which are expected by the end of 2004, will measure performance, particularly in high-risk patient group subsets, such as diabetics and patients with long lesions and small-diameter vessels. Diabetics represent 32 percent of the study's population.
(source: Cordis Corporation)

February 12, 2004
Medtronic Receives FDA Conditional Approval To Begin The Endeavor III Drug Eluting Coronary Stent Clinical Trial
Company press release announces that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin its ENDEAVOR III Clinical Trial, the third clinical trial in a series of studies to support global product approval of Medtronic’s investigational Endeavor™ Drug Eluting Coronary Stent.
(source: Medtronic, Inc.)

February 10, 2004
Stents Rivalry to Intensify as Boston Scientific Enters Market
Business-oriented article about the coming competition in drug-eluting stents.
(source: Jeff Karoub, Small Times)

February 10, 2004
MIV Therapeutics Successfully Completes Government-sponsored Drug-Eluting Stent Coating R&D Program
A company press release details the latest in their research program to develop multilayer biocompatible and bioactive calcium phosphate functionally graded coatings on stents.
(source: MIV Therapeutics, Inc.)

February 6, 2004
Boston Scientific Announces Completion of FDA Inspection of Minnesota Drug-Eluting Stent Manufacturing Facility
The FDA team reported no observations during the inspection and indicated it intends to recommend to the FDA that the Maple Grove facility be approved to manufacture the TAXUS™ Express2™ paclitaxel-eluting coronary stent system for the U.S. market. "This brings us an important step closer to approval of the TAXUS system in the U.S.," said Jim Tobin, President and Chief Executive Officer of Boston Scientific.
(source: Boston Scientific Corporation)

February 4, 2004
Boston Scientific Announces Start of Enrollment in U.S.-Based Drug-Eluting Stent Registry
Company announces the ARRIVE registry, which plans to enroll 2,000 patients at approximately 50 centers in the United States to collect and analyze "real- world" safety and clinical outcomes data for the TAXUS™ Express2™ paclitaxel-eluting stent system.
(source: Boston Scientific Corporation)

February 2, 2004
Boston Scientific Announces Results for Fourth Quarter and Year Ended December 31, 2003
The company's sales were up 15% over last year's 4th quarter. Jim Tobin, President and Chief Executive Officer stated, " We further strengthened our market leadership position in drug-eluting stents in Europe and other international markets...Our impressive performance in these markets gives us further confidence as we prepare to launch our TAXUS™ paclitaxel-eluting stent system in the United States later this quarter."
(source: Boston Scientific Corporation)

February 2, 2004
Panelists debate pathway to best drug-eluting stent use
A report on the drug-eluting stent panel at the 16th annual Piper Jaffray Health Care Conference -- some "real-world" comments by interventional cardiologists on the current use and future of these devices.
(source: Holland Johnson, BioWorld Today)

January 30, 2004
Court Sets Schedule for Drug-Eluting Stent Litigation Between Boston Scientific and Johnson & Johnson
Company announces details of June 2005 trial regarding patents on the Taxus and Cypher drug-eluting stent systems.
(source: Boston Scientific Corporation)

January 29, 2004
Boston Scientific Announces French Reimbursement for Taxus™ Express2™ Paclitaxel-Eluting Stent System
Company press release announces that France has approved their drug-eluting stent for reimbursement for patients treated in private clinics and hospitals. France is the second largest market for coronary stents in Europe and more than half these patients are treated in private clinics and hospitals.
(source: Boston Scientific Corporation)

January 21, 2004
J&J's Cypher Sales Raise Concerns on Market Penetration
This business news article analyzes sales figures from J&J's drug-eluting stent and discusses it in respect to the technology, cost and performance in the light of its pending competition with other products.
(source: Daniel Rosenberg, Dow Jones Newswire)

January 20, 2004
When It Comes to Drug Eluting Stents, Money Is No Object
In a survey of invasive cardiologists, MedCompare reports that price is only rarely a consideration in the decision to use drug-eluting stents over bare metal stents for angioplasty procedures; more often anatomy is the deciding factor.
(source: Silicon Valley Business Ink)

January 20, 2004
CYPHER™ Sirolimus-eluting Coronary Stent: Delivers on Clinical Promise
In the second company press release about the CYPHER stent in as many days, the company states, "Nearly 500,000 patients have been treated with the CYPHER™ Stent in more than 80 countries around the world, with more than 350,000 of them treated in the U.S. since Food and Drug Administration (FDA) approval in April 2003." The CYPHER is the only drug-eluting (sometimes called "drug-coated") stent currently approved for sale in the United States.  Boston Scientific's TAXUS stent was recommended for approval by an FDA panel in November and is hoping for final approval in the first quarter of this year. Other companies such as Guidant and Medtronic are in clinical trials. All use different drugs in the coating.
(source: Cordis Corporation)

January 19, 2004
15,000-Patient Interventional Cardiology Registry To Evaluate Impact of Drug-Eluting Coronary Stents
In its press release, the company today "announced plans to initiate the D.E.S.cover(sm) Registry, one of the most comprehensive interventional cardiology registries to date. Enrollment in the registry is scheduled to begin in first quarter 2004, and will include approximately 15,000 patients at more than 200 U.S. hospitals." The idea is to track more comprehensively the outcomes of patients who have been treated with stents and angioplasty. This registry seems to be an expansion of the Fall 2003 follow-up ordered by the FDA.
(source: Cordis Corporation)

January 15, 2004
A Polymer-Based, Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease
Abstract of the journal article (the full-text version is available to NEJM subscribers only) which details the data from the Taxus IV study, some of which were presented at this fall's TCT meeting. The study contrasted patients who received bare metal stents with those who received the Boston Scientific Taxus drug-eluting stent. The restenosis (reclosure) rate was 26.6% for the bare stents compared with 7.9% for the Taxus.
(source: New England Journal of Medicine)

January 14, 2004
Stent With Cancer Drug Shines in Trial
This article expands upon the New England Journal report (above) regarding the Taxus stent.
(source: Adam Marcus, HealthDay)

January 14, 2004
Medtronic Stent Trial Enrollment Done, Re-Submits IDE
Company press release reports that they have completed enrollment in the Endeavor II drug-eluting stent trial and hopes for a European launch in late 2004.
(source: Daniel Rosenberg, Dow Jones Newswire)

January 13, 2004
Boston Sci CFO Hopes For Quick US Plant OK From FDA
Larry Best, CFO of Boston Scientific comments on the pending approval of the Taxus drug-eluting stent in the U.S. He states, "We have our fingers crossed for a February approval."
(source: Daniel Rosenberg, Dow Jones Newswire)

January 13, 2004
Boston Scientific Announces Preliminary Results for Fourth Quarter and Year Ended December 31, 2003
The company announces its financial information and also notes that the FDA inspection team has recommended approval of Galway drug-eluting stent manufacturing facility, which moves the pending approval of the Taxus drug-eluting stent forward.
(source: Boston Scientific Corporation)

January 8, 2004
Boston Scientific and NitroMed Extend Collaboration on the Development of Nitric Oxide Coated Stents; Companies Extend Development Agreement for Two Years
NitroMed has been conducting trials with their drug BiDil® that releases nitric oxide, known to inhibit vascular smooth muscle proliferation, platelet adhesion and aggregation, and local inflammation. The drug has been particularly of interest for treating African-American patients who have lower nitric oxide levels. Boston Scientific is collaborating with the company to develop drug-coated stents using this agent.
(source: NitroMed, Inc.)

January 8, 2004
GenVec Enters Into Collaboration With Cordis Corporation
The companies are exploring a catheter system, using GenVec's vascular endothelial growth factor BIOBYPASS® to stimulate blood vessel growth in the coronary arteries.
(source: GenVec, Inc.)