December 29, 2005
Drug-Eluting Stents May Cause Allergic Reactions
A new study appearing in next week's Journal of the American College of Cardiology reports on a phenomenon that is not news to us here at Angioplasty.Org: allergic reactions to drug-eluting stents. Our Forum Topic has received almost 90 postings from patients on the subject, most in the past two years since the introduction of drug-eluting stents. The Northwestern study used a number of sources for the adverse reactions, among them the FDA MAUDE database. The study found definite allergic reactions to the stents themselves -- possibly to the polymer coatings on the stents. Symptoms included rash, difficulty breathing, hives, itching and fevers. (Read more...)

December 13, 2005
Guidant Enrolls First Patient in Japan Arm of Drug Eluting Stent Trial
(source: Guidant Corporation)
The company announced today that it has now begun enrollment in the Japan arm of its SPIRIT III drug eluting stent clinical trial evaluating XIENCE™ V, an everolimus eluting coronary stent system utilizing Guidant's cobalt chromium MULTI-LINK VISION® Coronary Stent System rapid exchange platform.

December 13, 2005
Medtronic Announces First Clinical Trial Experience With Next-Generation Drug-Eluting Coronary Stent System
(source: Medtronic, Inc.)
This next-generation drug-eluting stent will use the popular Driver™ bare metal cobalt alloy stent platform and the drug Zotarolimus (ABT-578), licensed from Abbott, along with the proprietary, biocompatible drug delivery polymer developed by Medtronic. Prof. Ian Meredith, Monash Medical Centre, is the principal investigator of the Medtronic RESOLUTE clinical study evaluating the new stent. This first-in-man study will enroll up to 100 patients at 12 clinical sites in Australia and New Zealand. The new polymer will allow more precise and adjustable rates of drug release.
related stories:
Medtronic begins test of new stent -- Reuters

December 1, 2005
Italian Ministry of Health Assigns Higher Price Premium to CYPHER® Sirolimus-Eluting Coronary Stent
(source: Cordis Corporation)
According to this company press release from Cordis / J&J, the Italian government's Commissione Unica Dispositivi medica (CUD) – the National Committee for Medical Devices -- has decided to pay more for the Cypher drug-eluting stent -- a 23% higher price than other drug-eluting stents on the market, due to lower costs associated with re-intervention. Brian G. Firth, Cordis worldwide VP of medical affairs and health economics, states, "CUD's analysis has shown that initial treatment costs combined with minimal costs of follow-up and long-term care for patients with the CYPHER® Stent offer a clear advantage over other commercially available drug-eluting stents."

December 1, 2005
Conor Medsystems Receives FDA Approval for Full Expansion of COSTAR II Drug Eluting Stent Trial
(source: Conor Medsystems, Inc.)
The company announced that it has received FDA approval to expand its randomized clinical trial to a full cohort of 1,700 patients. The trial will compare Conor's COSTAR II drug-eluting stent to Boston Scientific's Taxus (patent lawsuit and countersuits have been filed). The results should be more than interesting because Conor's stent uses the same drug (paclitaxel) as the Taxus, but the drug delivery system differs. In the Boston stent, a polymer which controls the release dose of the drug is coated on the entire stent. The drug gets released in the first few months and the inner lining of the artery covers the polymer-coated stent over time. In the Conor stent, a bioresorbable polymer containing the drug is loaded into hundreds of small holes or reservoirs in the stent's metal surface. Once the polymer has released its drug over time, it is absorbed into the body, leaving no residue, and the Conor COSTAR II stent, for all intents, becomes a bare metal stent. There have been some concerns (most recently expressed by Dr. Renu Virmani at this year's TCT) that non-resorbable polymers on the two currently available drug-eluting stents may delay healing of the artery and be a cause for late stent thrombosis (clotting) which, while low in occurrence, is fatal almost half the time. Her research showed no such effect in bare metal stents, so the results of the CONOR trial will be closely watched.
related stories:
Conor says FDA approves widened stent trial -- Reuters
Suit and Countersuit: Angiotech Trades Barbs with Conor Medsystems -- Medical DeviceLink

November 29, 2005
SurModics' Hydrophilic Coating on Medtronic Endeavor™ Drug-Eluting Stent Delivery System
(source: SurModics, Inc.)
Company announces that it has licensed its advanced hydrophilic technology to Medtronic for use on their Endeavor drug-eluting stent delivery system to make the catheter that carries the stent more "lubricious". SurModics also makes the BRAVO™ polymer that is used on Cordis/J&J's Cypher™ stent.

November 28, 2005
Drug-coated stents equally effective
(source: Karen Garloch, Charlotte Observer)
A report quoting Dr. Charles Simonton of the Sanger Clinic in Charlotte, North Carolina, who headed up the 14,000 patient STENT Registry, comparing the Taxus and Cypher stents. He states, "These two stents are performing almost identically.... There's no reason why an interventional cardiologist ought to pick one over the other based on the way patients are turning out."
related stories:
Trends Favour Boston Scientific's TAXUS Stent Over J&J's Cypher in Interim 9-Month Data From Largest Independent DES Registry in US -- Boston Scientific
The Company has a slightly different interpretation of the data than the STENT registry's lead investigator.
Déjà Lu: "already read" -- Voice in the Ear: The Stent Blog
Can you step into the same press release twice?

November 26, 2005
Boston Scientific Says Its Stent Has An Edge Over J&J
(source: Wall Street Journal $$)
Paul LaViolette, COO of Boston Scientific, tells the Wall Street Journal that a study the company commissioned showed that its Taxus stent may have a "considerable advantage" over the competing Cypher stent, made by Johnson & Johnson. A review and analysis of FDA "adverse report" records made by Certus International showed a significantly larger number of reports of restenosis (renarrowing) or thrombosis (clotting) with the Cypher stent. Terri Mueller of Cordis/Johnson & Johnson called Boston Scientific's statement "inappropriate and misleading," while Dennis Donohoe, Cordis' VP for regulatory affairs pointed out that the FDA database was not meant to be used for these types of analyses, which are better determined through clinical trials. The ongoing "Stent Wars" between these two rivals have bred much controversy. Most clinical trials have shown the two stents roughly equivalent in regard to thrombosis and restenosis; some smaller single center trials have shown that Cypher is better at preventing restenosis.
related stories:
My Night With MAUDE -- The Voice in the Ear: The Stent Blog
Can the FDA adverse events database really be used to show superiority of one device over another? Here's a hint: NO!

November 16, 2005
J&J-Guidant merger to shake up stent market
(source: Stephen Heuser, Boston Globe)
An analysis of the impact of J&J buying Guidant on Boston Scientific and the stent market in general.

November 15, 2005
Boston Scientific questions Michigan center's complaints
(source: St. Paul Pioneer Press/Bloomberg News)
Boston Scientific said problems with its heart stents at Michigan's busiest cardiac center haven't occurred elsewhere and, according to this article, suggested that doctors may have mishandled the devices. "It is essential to follow the directions for use...It appears that some individuals at Beaumont are not satisfied, but their dissatisfaction is out of all proportion to our experience at more than 1,000 cardiac catheterization labs,"" said Boston Scientific spokesman Paul Donovan.

November 15, 2005
Guidant Reports Excellent 12-Month Results from SPIRIT FIRST Everolimus Eluting Coronary Stent Clinical Trial
(source: Guidant Corporation)
One year results from the XIENCE V drug-eluting stent were impressive, says principal investigator Prof. Patrick W. Serruys, M.D. of Rotterdam. He continues, "The benefit of an everolimus drug eluting stent, with only one device-related MACE event and no thrombotic events, combined with the highly deliverable rapid-exchange VISION stent and stent delivery system, holds great promise for the treatment of patients with cardiovascular disease." Results were presented at the AHA Scientific Sessions in Dallas.

November 14, 2005
Hospital's Suspension of Boston Scientific Stent Gets FDA Review
(source: Wall Street Journal $$)
According to an article in today's Wall Street Journal, the FDA is evaluating the temporary suspension in the use of the Taxus stent enacted 7 weeks ago by Dr. William O'Neill of William Beaumont Hospital in Michigan, where over a 5-day period, three Taxus system balloons had difficulty being withdrawn, and caused some injury to arterial linings. The problem is different than the one which prompted a voluntary recall of the Taxus stent in the summer of 2004, which had to do with a possible weak laser weld in the catheter shaft. This new problem, if in fact it is one, seems related to the balloon, not the stent. A stent is delivered to the artery on a balloon which is inflated, thus expanding the stent into the desired position; the balloon is then deflated and pulled out, leaving the stent behind. Withdrawal of the balloon should be uneventful, which doesn't seem to be the case here. There have been some perceptions of balloon "stickiness" since soon after the Taxus stent was introduced although, according to a company spokesperson, complaints are less than 1 in 10,000. Some physicians have posited that the polymer coating of the stent can cause the balloon to stick to the expanded stent and have difficulty deflating or withdrawing after the stent has been delivered. Use of the stents was reinstated by Dr. O'Neill after assurances from the company were made that there were no defects in the product and Boston Scientific trainers visited the hospital to work with the doctors. At issue is a complaint from Dr. James Goldstein, a cardiologist at the hospital, that Boston Scientific implied the issue has been "solved". His feeling is that the problem has not been solved -- and now the FDA has stated that it "does not consider this situation to be a 'closed' matter." Stay tuned.
related stories:
FDA reviews Taxus complaints in Michigan -- Reuters

November 10, 2005
Guidant Completes Enrollment in International Drug Eluting Stent Clinical Trial
(source: Guidant Corporation)
SPIRIT II is a 300-patient randomized clinical trial evaluating XIENCE™ V, an everolimus eluting coronary stent system utilizing Guidant's cobalt chromium rapid-exchange MULTI-LINK VISION® Coronary Stent System platform. Prof. Patrick W. Serruys, M.D., of the Thoraxcenter, Erasmus University Hospital, Rotterdam, serves as the trial's principal investigator. "The SPIRIT II trial will continue to evaluate the clinical experience of XIENCE V, which demonstrated excellent six-month results in the SPIRIT FIRST trial reported last fall," said Prof. Serruys. "We look forward to the presentation of additional results from SPIRIT FIRST at the American Heart Association Scientific Sessions next week."

October 27, 2005
Competing medicated stents work equally well - Most comprehensive USA clinical trial to date shows
(source: Carolinas HealthCare System)
After completing the most comprehensive U.S.-based study of its kind, Dr. Charles Simonton reported that the performance of two competing coronary stents was “virtually identical” in head-to-head comparisons. The STENT registry, which now includes approximately 14, 000 patients, is the first of its kind to gather data from multiple sites, including eight medical centers located throughout the Southeast. The registry also includes one of the largest patient follow-up efforts based on a profile of the general populace.
related stories:
TAXUS® Stent Demonstrates Excellent Efficacy and Safety in Independent 'STENT' Registry -- Boston Scientific
Press release from the manufacturer of the Taxus stent claims a "numeric trend" favors their stent.
The Numbers Game-- The Voice in the Ear
Commentary on statistical claims and the marketing of stents and how it affects patients.

October 22, 2005
Boston Scientific Heads to the Recovery Room
(source: Barron's Online)
An interesting overview of the rises and falls of Boston Scientific in the drug-eluting stent era. When Boston's Taxus was introduced in March 2004, it quickly captured two-thirds of the market. Then last summer's recalls, along with studies presented at the ACC in March which seemed to show Cypher superiority (even though the major trial was in fact a draw) -- these events took their toll and last Tuesday, J&J proudly reported that Cypher U.S. market share had increased to 46%. Boston hopes to regain much of this lost business with its new Liberte stent, hopefully to be approved later this year or early 2006. But the company still seems to be on the defensive -- Chief Financial Officer Larry Best complains in the article, "We've got a growth story with Taxus, and no one wants to listen to it." And later he says management would even entertain offers for the entire company. "We're shareholders," he says, "and everything's for sale." Insiders, a group to which Mr. Best would belong, own 35% of the company.

October 21, 2005
Some Doctors See Long-Term Clot Risk In Stent Patients
(source: Wall Street Journal -- $$)
We at Angioplasty.Org have been on this story for two years now. Back in the fall of 2003, some late stent thrombosis that appeared in Cypher patients caused alarm. The data were investigated and it was concluded, correctly so, that the stent thrombosis rate of less than 1% was comparable to that seen in bare metal stents. When Taxus stents were introduced, most studies showed similar rates (notwithstanding Johnson & Johnson / Cordis' campaign that attempted to imply that Taxus was less safe). Then just this spring came a study from Antonio Colombo's group that showed a real-world thrombosis rate double that in the clinical studies. And now several reports at the TCT are showing a small number of patients who have developed thrombosis (clotting) at up to three years. Dr. Renu Virmani showed her study of 40 drug-eluting stent patients who had died from cardiac causes -- 60% of them had a blood clot in their drug-eluting stent. Of great importance was the fact that all these patients also had bare metal stents from earlier interventions: none of these stents showed clots. So the late stent thrombosis problem seems to be a class effect for drug-eluting stents, emphasizing that antiplatelet therapy is critical after the procedure and more and more doctors now think should be extended well beyond the recommended minimum 3-6 months.
related stories:
"Free" reprint of above WSJ article -- Pittsburg Post-Gazette
Doctors study risk of clots in new stents -- Boston Globe

October 21, 2005
Conor Medsystems Presents Positive Clinical Data From EuroSTAR and COSTAR I Studies
(source: Conor Medsystems, Inc.)
The data from two studies have solidified Conor's decision to move forward with a dose of 10mcg of the drug paclitaxel on its drug-eluting stent the CoStar, which may see approval in Europe by the end of this year. The results show restenosis rates similar to those of the two currently U.S.-approved stents made by Boston Scientific and Cordis. The CoStar embodies a different design which the company touts as being crfeated specifically for drug delivery, rather than being an older bare metal stent that has been retrofitted for that purpose. Several potential advantages of the CoStar are ease-of-use, more deliverability, and the complete absorption of the drug and its delivery medium by the body, leaving no polymer behind after about 6 months -- this may have implications in the growing concern over late stent thrombosis (blood clots that may develop even 1 or 2 years after implantation of polymer-coated drug-eluting stents -- this only has occurred in a small percetnage of patients, but it is very serious) -- the CoStar has shown no stent thrombosis so far.
related stories:
Crashing The Stent Party -- BusinessWeek Online
Conor Medsystems to Pursue Drug Stent -- Associated Press

October 21, 2005
Sirolimus-Eluting Coronary Stent Outperforms Paclitaxel Eluting Stent in Seven Study Meta-Analysis
(source: Cordis Corporation)
In this press release, a seven study "meta-analysis" shows the Cypher stent outperforming the Taxus stent. While it is true that virtually all studies have shown the Cypher sirolimus stent to be equal to or slightly better than its Taxus paclitaxel rival in TLR (Total Lesion Revascularization) one can also find that the two are equal, depending on which definition of success one uses. For example, the TCTMD.com's "Evidence-Based Medicine Center". using guidelines fashioned along those of the European Society of Cardiology, finds that Taxus and Cypher are not so different -- of course, the EBMC is "is made possible by support from Boston Scientific Corporation".

October 20, 2005
TAXUS® Express2™ Stent System Shows Significant Reduction of Restenosis in Diabetic Patients in Clinical Trial
(source: Boston Scientific Corporation)
A subset of data from Boston Scientific's Taxus V clinical trial showed marked reduction in restenosis for diabetic patients, who are at increased risk for having their arteries close up again after stenting. At 9-months the Taxus stent group had a reclosure rate of 9.6 percent compared with 17.5 percent in the control group of bare metal stents -- a 45% reduction, interestingly the same amount of reduction as in the non-diabetic population -- the Taxus stent restenosis prevention effect seems to work across the board.

October 20, 2005
New Analysis Suggests the CYPHER® Sirolimus-Eluting Coronary Stent is Cost Effective in the Treatment of Multi-Vessel Disease Versus Bypass Surgery
(source: Cordis Corporation)
This analysis shows that the use of drug-eluting stents over bypass surgery is less expensive by 21-29%, even though drug-eluting stents, such as the Cypher, cost between $2,000-3,000@.

October 20, 2005
OLYMPIA Registry Supports Positive Safety Profile of TAXUS® Liberte™ Stent System
(source: Boston Scientific Corporation)
The company moves forward with its Liberte platform.

October 20, 2005
Study Finds Excellent Results in Patients with Long Lesions Treated with Multiple and Overlapping CYPHER® Sirolimus-Eluting Stents
(source: Cordis Corporation)
Dr. Campbell Rogers of Brigham & Women's Hospital in Boston presented a detailed analysis of data pooled across four drug-eluting stent clinical trials at this year's TCT. The analysis finds that high risk patients with long coronary blockages had better clinical outcomes with multiple, overlapping or non overlapping, CYPHER® Stents than those patients who received bare metal stents.

October 17, 2005
New Study Results Suggest Better Outcomes With The CYPHER® Sirolimus-Eluting Coronary Stent Than Brachytherapy In Patients With In-Stent Reblockage
(source: Cordis Corporation)
Not that this is any surprise, since brachytherapy (radiation therapy) is not really being used much anymore in interventional procedures. The conundrum here is that brachytherapy is currently the ONLY FDA-approved treatment for in-stent restenosis, yet it's been known that drug-eluting stents work better -- cardiologists in fact sometimes use them "off-label" -- perhaps studies such as this will help the FDA expand the approved indications.

October 17, 2005
ENDEAVOR III Confirmatory Study Demonstrates Clinical Outcomes Consistent With Previous Endeavor Trials
(source: Medtronic, Inc.)
The headline doesn't read this way, but the Endeavor III Trial, as some had predicted, failed to meet its endpoint, albeit very narrowly, to show non-inferiority with the Cypher stent. The real meaning of this is that Medtronic's entry into the U.S. market may be delayed since the FDA may want to see the results of Endeavor IV before granting approval. (Endeavor IV pits the Medtronic stent against Boston's Taxus.) Medtronic still feels that they will see approval in 2007; others in the device industry have told Angioplasty.Org they think 2008 may be more realistic.
related stories:
Medtronic stent study narrowly misses goal -- Reuters
Medtronic Stent Undershoots Target -- TheStreet.com

October 14, 2005
Cordis Corporation Announces Broad Range of Clinical Studies and Events for the CYPHER® Sirolimus-eluting Coronary Stent at TCT 2005
(source: Cordis Corporation)
Schedule for presentations of drug-eluting stent trials, etc. at next week's big interventional cardiology meeting in Washington.

October 14, 2005
Boston Scientific cuts outlook amid loss
(source: Debra Sherman, Reuters)
Due to its $750 million settlement with Medinol and lower domestic sales on their Taxus drug-eluting stent, Boston Scientific reported a loss in its 3rd quarter.
related stories:
Boston's Forecast Comes Up Short -- TheStreet.com

October 13, 2005
Boston Scientific Wins Appeal in Patent Infringement Case Against Johnson & Johnson in the Netherlands
(source: Boston Scientific Corporation)
Back in June, a Dutch court ruled against Cordis on a patent infringement issue involving not their stent, but the shaft of the catheter used to deliver the stent-on-a-balloon. The court also issued an injunction against the sale by Cordis of products using this patent (this included the Cypher). Cordis appealed the verdict and in July, another court lifted the injunction temporarily while the full apeal was being decided upon. Today the court ruled against J&J/Cordis and the injunction is now back in full force.
related stories:
Boston Scientific wins Dutch patent appeal over J&J -- Reuters

October 13, 2005
Boston Scientific Announces 'TAXUS® Stent Assurance Program'
(source: Boston Scientific Corporation)
In a first-of-kind program, the company announced that it will replace for free any Taxus stent that requires re-intervention in a patient. The offer will run during calendar year 2006 and is good only to hospitals that enroll in the program through their sales representatives. More details can be found in this description on Boston Scientific's website. (comment on this story.)
related stories:
Stent maker to offer free replacements -- Boston Globe
Dr. Campbell Rogers, a cardiologist at Brigham and Women's Hospital, said the guarantee was ''intriguing" but questioned whether it would be practical for doctors and hospitals to reap the benefits. The terms of the deal require hospitals to pre-enroll with a Boston Scientific salesperson and submit multiple documents to prove the artery has reclogged inside the stent.
Boston Scientific sees no Taxus share loss in quarter -- Reuters
Paul LaViolette (COO of the company) states that there has been no loss of market share to Johnson & Johnson's competing Cypher stent in the 3rd quarter (this is contrary to some analysts' predictions) and also that all problems stemming from last summer's recall are fixed "definitively". The article has also been recently updated to include commentary on Boston's "money-back guarantee".

October 11, 2005
Medtronic to present key drug-eluting stent data next week
(source: Daniel Rosenberg, MarketWatch.com)
Good overview of the issues facing Medtronic next Monday when the data from the Endeavor drug-eluting stent trials is presented at the TCT meeting in Washington.

October 10, 2005
Never a Dull Moment for Device Makers
(source: Althea Chang, TheStreet.com)
An good wrap-up of where the various stent companies stand, as they approach "TCT-week", starting next Sunday..

October 10, 2005
Boston Scientific to Release Long-Term Clinical Trial Results on Market- Leading TAXUS® Express2™ Coronary Stent System at TCT 2005
(source: Boston Scientific Corporation)
Schedule for presentations of drug-eluting stent, carotid trials, etc. at next week's big interventional cardiology meeting in Washington.

October 10, 2005
Medtronic, Inc. Webcast Notice: Medtronic Vascular Update
(source: Medtronic, Inc.)
Schedule for webcast at next week's TCT interventional cardiology meeting in Washington.

October 10, 2005
Johnson & Johnson Outlook Boosted By Cypher
(source: Forbes.com)
Several analysts expect Johnson & Johnson to announce strong gains in market-share of drug-eluting stent, following Boston Scientific's problems over the summer and clinical studies that have shown Cypher edging out the Taxus in the most complex patients.

October 10, 2005
Medtronic Submits First PMA Module to the U.S. Food and Drug Administration for Endeavor™ Drug-Eluting Coronary Stent
(source: Medtronic, Inc.)
Kind of "they're off!" in the stent races -- Medtronic is starting the process in the U.S. that it hopes will lead it to become the third drug-eluting stent marketed there.

October 6, 2005
FTC ruling key to Medtronic stent plans
(source: Reuters)
While results from Medtronic's latest clinical trial for its Endeavor drug-eluting stent will be presented at this year's TCT, a bigger question for the company's future program will be an FTC ruling about whether Johnson & Johnson will be required to license its rapid exchange technology to other companies as part of its planned merger with Guidant. If it is, J&J is expected to license the technology to Abbott, in a bid to keep Medtronic from overtaking a share of its market (currently shared with Boston Scientific). A rapid exchange system (which J&J, Guidant and Boston all have) is considered critical to success in the angioplasty market.

October 6, 2005
Guidant Launches Cobalt Chromium Coronary Stent System in Japan
(source: Guidant Corporation)
The rapid-exchange MULTI-LINK VISION® RX Stent System is made of cobalt chromium, unlike the current generation of metal stents which are made of stainless steel. Cobalt chromium is a stronger metal, thus allowing a stent to be made with thinner struts -- exposing less stent to the bloodstream and hopefully lowering the restenosis rate. Guidant is using the VISION stent as the foundation for its own drug-eluting stent program, the XIENCE™ V, currently in a clinical trial comparing it to Boston Scientific's Taxus.

October 6, 2005
Cook Launches Web Site for Patients Seeking Information About Peripheral Arterial Disease
(source: Cook Inc.)
The new website includes information about symptoms, prevention and treatment of Periperal Arterial Disease (PAD). Consumers also can download information to determine with their physicians whether they may be eligible to participate in a worldwide clinical trial testing the safety and effectiveness of the Zilver® PTX™ Drug-Eluting Stent. This is the first-ever clinical trial to test a paclitaxel-eluting stent to treat PAD.

October 3, 2005
Drug-Coated Stents Better for Diabetics
A study of 160 patients from Spain adds to the growing body of evidence that diabetics, a patient population previously considered high risk for reblocking after angioplasty/stenting, can be successfully treated with drug-eluting (drug-coated) stents. Comparing bare metal stents to a drug-eluting sirolimus stent (this would be the Cypher, made by Cordis/J&J) the need for a repeat angioplasty was 5 times higher in the bare metal group; the occurrence of a Major Adverse Cardiac Event (MACE) was almost 4 times higher. A spokesman for the American Heart Association states in the article that the study is "good news for patients with diabetes."
(source: Ed Edelson, HealthDay)

September 26, 2005
Medinol to seek royalties from Boston Scientific
(source: MSNBC)
In the "not so fast" category, less than a week after announcing a settlement (see below) of its long-standing dispute with Medinol, Boston Scientific finds itself again the target of legal action by the Israeli firm, which is now claiming royalties due from the Taxus Liberte stent, Boston Scientific's second-generation device, now approved in Europe. While Boston Scientific feels the claims are without merit, J.P. Morgan analyst Michael Weinstein states, "The issue for investors is that the Boston Scientific press release made it seem like there was closure to the Medinol issue, when clearly there is not.... What Medinol said today is, no, there is not closure after October 25."

September 26, 2005
U.S. FTC eyes licensing plan for J&J-Guidant deal
(source: Reuters)
In a new wrinkle to the possible requirement that J&J/Guidant share their "rapid exchange" technology to gain merger approval from the Federal Trade Commission, recent reports are that they may be directed to license the technology specifically to Abbott, leaving Medtronic and other balloon and stent manufacturers out in the cold. Medtronic is not pleased with this turn of events, and is taking its objections directly to the four FTC commissioners.

September 23, 2005
Battle of the Drug-Eluting Stents
(source: Journal Watch Cardiology)
Commentary on the several studies published in August comparing the sirolimus (Cypher) and paclitaxel (Taxus) drug-eluting stents. Conclusion was that the sirolimus peformed somewhat better in terms of less restenosis, but that "for many patients, the sirolimus stent’s clinical advantages might be outweighed by the paclitaxel stent’s greater ease of delivery and by cost differences." Also with a new generation of stents coming along, these conclusion may need revision.

September 21, 2005
Boston Scientific and Medinol Announce Settlement
(source: Boston Scientific Corporation)
The long-standing legal dispute between Israeli-based Medinol and Boston Scientific has been resolved -- and for the mere price of $750 million dollars!! Briefly stated, Boston Scientific had an exclusive supply agreement with Medinol for stents (a model no longer marketed -- the NIR stent) but when difficulties arose between the two, Boston Scientific secretly reverse-engineered the NIR and built an assembly line behind locked doors in their Ireland plant. This information was communicated to Medinol by Jim Tobin, CEO of Boston Scientific, who admitted it was wrong. However, Boston claimed that Medinol has reneged on their agreement to supply sufficient stents and that Boston took its action to protect its product availability. Medinol also claimed that Boston Scientific infringed on their stent patents in the design of the currently marketed Express and Taxus Express stents. Kobi and Judith Richter, owners of Medinol, previously rejected smaller settlement offers. While this agreement represents a large cash outlay for Boston Scientific, it brings to a close a big unknown that had the investment community concerned about whether a court might order an injunction against sale of the Taxus stent, Boston Scientific's big profit-center.
Boston Scientific settles with Medinol for $750 mln -- Reuters
Boston Scientific Settles Spat -- Wall Street Journal ($$)

September 19, 2005
J&J/Guidant may license stent technology
(source: Susan Kelly, Reuters)
J&J and Guidant may have to make their "rapid exchange" technologies available to other companies for purchase in order to gain Federal regulators' approval of their upcoming merger. Neither Medtronic nor Abbott, who are looking at 2006-7 for introduction of their drug-eluting stents into the U.S. market, currently have this technology and both are anxious to get it. Boston Scientific has its own rapid exchange system (gained when it acquired Schneider -- the first manufacturer of angioplasty devices) and probably has the most to lose from this licensing. In brief, rapid exchange is a two-handed system which allows one operator (the cardiologist) to perform the entire angioplasty; the original system requires four hands: two to hold the guiding catheter and advance the balloon or stent and two more to hold and steer the guide wire component, requiring the cardiologist and an assistant.
Medtronic May Seek to Buy Popular Stent Technology -- Wall Street Journal ($$)

September 16, 2005
Medtronic Completes Patient Enrollment In Endeavor III Clinical Trial
(source: Medtronic Inc.)
The company has completed enrollment in its clinical trial, comparing the performance of its Endeavor drug-eluting stent to that of the Cypher sirolimus stent, made by Johnson & Johnson/Cordis. Results of this trial will be presented at this October's TCT meeting in Washington.

September 4, 2005
Key Clinical Data Shows That The Endeavor™ Drug-Eluting Stent Sustains Strong Safety And Efficacy Performance Over Time
(source: Medtronic Inc.)
The first two Endeavor trials were reported at 12 and 24 months with the results that restenosis has been kept in check and there has been no late stent thrombosis. Results from the Endeavor III trial will be announced at the TCT conference in October.

September 1, 2005
Importance of Antiplatelet Therapy with Drug-Eluting Stents
(source: U.S. Food and Drug Administration)
A problem that Angioplasty.Org has been stressing for two years now: the danger of premature withdrawal of antiplatelet therapy (aspirin and/or Plavix). In the fall of 2003, not long after Johnson & Johnson's Cypher stent was approved, reports started coming in about late stent thrombosis -- the sudden (and often fatal) formation of a blood clot at the site of the stent. This only occurred in a very small number of patients and, as we suggested then and several studies have since proven, the cause of some of this thrombosis is that patients stopped taking their antiplatelet drugs. Sometimes they were told to because they needed to have surgery, or a dental procedure. Read the FDA's warning -- it's even on video.

August 24, 2005
Warning Letter to Boston Scientific -- Dated August 10, 2005
(source: U.S. Food and Drug Administration)
Yesterday the FDA made public a fairly strong warning letter it had sent to Boston Scientific regarding problems at its Quincy, Massachusetts shipping facility in which somehow drug-eluting stents that had been quarantined for failure to pass a quality control test were shipped to 5 hospitals. Supposedly this occurred when an employee or employees over-rode a computer block on these items. Charles Rudnick, a spokesperson for the company stated that "None of the products resulted in any harm to patients." He continued that they were shipped in error and, in most cases, had been retrieved from the hospitals immediately.
Boston Sci receives FDA warning -- MarketWatch.com

August 16, 2005
Studies Give Edge To J&J Stent
(source: Forbes)
Two studies to be published this week in New England Journal of Medicine and Journal of the American Medical Association show that J&J's Cypher is superior to Boston Scientific's TAXUS drug-eluting stent. Previously reported at the ACC in March, the SIRTAX and ISAR-DIABETES full studies will appear in NEJM, while a meta-analysis of almost 4,000 patients by Dr Adnan Kastrati of Munich will be published in JAMA. While the differences between stents are not large, they do seem to exist. One problem, however, is the supply of Cypher stents in all sizes is still not up to full levels; also in some cases, the Taxus seems easier to deliver to the artery.
American Journal of Cardiology Study Finds TAXUS Has Lower MACE Rate Than Cypher
(source: Boston Scientific Corporation)
Showing the exact opposite of the above trials and analyses, a small Dutch study of 293 patients showed that Taxus bested Cypher in 2 of 3 areas known as MACE (Major Adverse Cardiac Events) and basically tied in the third.
New meta-analysis rekindles Cypher-Taxus debate, fueled by publication of SIRTAX and ISAR-DIABETES
(source: theheart.org -- registration required)
A detailed report on these two studies with opinions from various cardiologists, our favorite is from Ron Waksman of the Washington Hospital Center who stated, "I think a large part of this is propaganda. Cordis is trying to show that its stent is superior to Boston Scientific's, and Boston Scientific is trying to show that there is no difference. So each company will pick up the pieces from the studies that fit their statements. When we look at our own Washington Hospital Center data, which now cover 2,500 patients, they do not show any difference between the two stents."

July 31, 2005
Medtronic Receives CE Mark Approval For Endeavor™ Drug-Eluting Coronary Stent System
Mark that number three -- Medtronic's Endeavor drug-eluting stent has now achieved the significant approval of the European community and the company is looking toward an U.S. approval next year, making the endeavor the third DES available. The Medtronics stent, interestingly enough, is coated with a drug made by Abbott, a company that is developing its own drug-eluting stent.
(source: Medtronic, Inc.)

July 19, 2005
Stent maker says legal disputes not major threat
Boston Scientific responds to concerns that its legal disputes with Johnson & Johnson and Medinol will become significant negatives for the company.
(source: Ross Kerber, Boston Globe)

July 14, 2005
Stent report dismissed
Both Boston Scientific and Federal regulators state that the problems raised in yesterday's Wall Street Journal article were "not related to the design flaw that led to a massive recall of the device a year ago". A Company spokesperson furthermore stated that the number of problems with balloon non-deflation were "exceedingly low" and that "You're always going to have problems with a balloon not deflating or getting stuck." Officials with the FDA agreed and that the reports are "within expectations" for the device. The Pioneer Press quotes a stock analyst saying, "It is unclear why this article was written, given this is an old issue."
(source: Jim McCartney, St. Paul Pioneer Press)

July 13, 2005
Boston Scientific Stent Problems Persisted
(source: Associated Press)
FDA sees no more action on stents despite injuries
(source: Reuters)
Stents Made by Boston Scientific Showed Problems After 2004 Recall
(source: Sylvia Pagan Westphal, Wall Street Journal -- subscription only)
A front page report in this morning's Wall Street Journal has raised questions about potential problems with Boston Scientific's Taxus stent, which was recalled by the company last summer. The article details cases (since the recall) in which the balloon on which the stent is mounted failed to deflate quickly, causing injury and in one or two cases, death to the patient. Failure of a balloon to deflate is a complex issue, that may or may not be a problem with the equipment itself -- many factors such as the anatomy of the specific artery, operator technique, etc. can interact. All devices have complication rates -- the question is whether the complication rate for a specific device is out of the ordinary. The FDA has examined these reports and, as of today, did not see that the adverse reports warranted any action. As Mark Landy of the Susquehanna Financial Group pointed out in the Reuters article above:

" With both drugs and medical devices, you get bad outcomes from time to time," adding the Wall Street Journal report followed a series of recent reports by The New York Times about problems with medical devices made by Guidant Corp. "It now appears that medical devices are in cross-hairs of journalists," he said.

Angioplasty.Org has previously written about the meaning of product recalls in its article, "What's A Patient To Do?" -- we will be updating this as more information is received about the problems that were raised today.

July 13, 2005
Drug-Eluting Stents Prove Mettle in Heart Attack Patients
Drug-eluting stents have shown great success in treatment of coronary artery disease but until now has not been studied in heart attack victims. This study, published in CCI: Journal of the Society for Cardiovascular Angiography and Interventions, shows very positive results in this population
(source: Catheterization and Cardiovascular Interventions)

July 1-2, 2005
Boston Scientific Announces Patent Infringement Verdict Against Johnson & Johnson
(source: Boston Scientific Corporation)
Cordis to Ask Judge to Overturn Patent Verdict
(source: Cordis Corporation)
Jury Finds Infringements on Patents on Stents
(source: Barnaby J. Feder, New York Times -- reg required)
Boston Scientific wins suit -- Patent ruling evens score in legal fight between stent rivals
(source: Ross Kerber, Boston Globe)
Another series of articles and company press releases that discuss the event surrounding today's jury finding that Johnson & Johnson / Cordis infringed patents owned by Boston Scientific -- these concern the polymer coating of drug-eluting stents and the so-called "Ding" patent. Damages will be decided upon later in August, but this now levels the playing field quite a bit. The last trial found that Boston Scientific infringed upon J&J's bare metal stent design. So in the past month juries have found that the patents for the stent structure, as well as aspects of the balloon-expandable process, belong to J&J, but that the patents for the polymer drug-coating process belong to Boston Scientific. This will, in our view, might to an accomodation down the line, but first J&J is asking the judge to reverse the jury's decision and also plans to appeal. Stay tuned.

July 13, 2005
Lack Of Major Heart Device Trials Hurts Sector's Luster
Article "laments" the lack of major clinical trials, such as the ones for drug-eluting stents and ICDs -- and paints a picture of the coronary medical device industry in, as Dr. Eric Topol calls it, the "evergreen phase" -- matured and not much movement. The article also quotes Paul LaViolette, COO of Boston Scientific, as saying that catheter-based treatment of carotid narrowing (stroke prevention) is going to be a growth area. We agree.
(source: Daniel Rosenberg, Dow Jones Newswires)

July 6, 2005
Guidant Begins Enrollment in European Drug Eluting Stent Study
The company announced the first patient enrolled in its SPIRIT II drug eluting stent clinical study for the everolimus coated XIENCE™ V. The cobalt-chromium stent is in trials in the U.S. and now in Europe.
(source: Guidant Corporation)

July 5, 2005
For J&J, device rewards outweigh risks--analysts say
A business overview of where J&J is, considering the recent stent patent rulings and their impending acquistion of Guidant, a company that has just gone through a much-publicized recall.
(source: Susan Kelly, Reuters)

June 28, 2005
Boston Scientific Heads Back to Court
A recounting of the various "trials" and tribulations that Boston Scientific is going through with lawsuits involving patnet infringement from Johnson & Johnson / Cordis, settlement of fines with the U.S. Department of Justice and now, the opening of the trial dealing with a long-standing dispute with Israeli-based Medinol.
(source: Barnaby J. Feder, New York Times)

June 22, 2005
Guidant Begins Enrollment in U.S. Drug Eluting Stent Trial
Guidant moves forward with it everolimus drug-eluting stent. Even though Johnson & Johnson / Cordis plans on acquiring Guidant later this year, this newest DES trial has begun -- and it is designed to compare the XIENCE V stent to Boston Scientific's Taxus.
(source: Guidant Corporation)

June 21, 2005
Patients Reap Benefits of Heart Health Advance
This press release from Cordis gives an overview of what the introduction of drug-eluting stents (the Cypher, in particular) has meant for patients. In our view, the impact of drug-eluting stents has changed the treatment pathways significantly from what they were only two or three years ago.
(source: Cordis Corporation)

June 21, 2005
Jury Finds Cordis Patents Infringed by Boston Scientific Stents
(source: Cordis Corporation)
Boston Scientific Announces Jury Verdict in Patent Litigation With Johnson & Johnson
(source: Boston Scientific)
Jury Rules Against Boston Sci In J&J Stent Patent Trial
(source: Wall Street Journal -- subscribers only)
Boston Scientific infringed J&J patent-jury
(source: Susan Kelly, Reuters)
Boston Scientific could face $1B in damages on patent infringements
(source: Boston Business Journal)
A series of articles and press releases regarding today's jury decision that Boston Scientific's stents infringed on two patents held by Johnson & Johnson / Cordis. This not unexpected ruling has no injunctive effect on the current supply of stents (i.e. Boston Scientific will not have to stop selling its market-share-leading Taxus stent) although the ruling that the second "Gray patent" is infringed upon by Boston Scientific's up-and-coming Liberte stent is potentially troublesome. The actual damages will be decided in another trial in August. Analysts have said that they could reach $1 billion. (Editor's Note: In a separate case, soon to go on trial, Boston Scientific is claiming patent infringement against Cordis for the polymer coating of its drug-eluting stent.)

June 20, 2005
Next-Generation TAXUS® Liberte™ Coronary Stent System Registry Completes First Enrollment Phase
The company announced that it has completed enrollment in the transitional phase of the world's largest drug-eluting stent registry. The OLYMPIA registry plans to enroll more than 30,000 patients at more than 600 centers in the United States, Europe and other international locations.
(source: Boston Scientific Corporation)

June 17, 2005
Medinol lawsuit heads back to court
Four-years in the making, this dispute has not been resolved through court-suggested mediation, so on June 27 the parties will find themselves facing each other in a New York court.
(source: Shirely Yom Tov, Haaretz)

June 9, 2005
Cordis Corporation to Appeal Court Ruling
(source: Cordis Corporation)
A Dutch court has ruled against Cordis and for Boston Scientific on a patent issue stemming from the catheter shaft for their balloon catheters, used to deliver the Cypher drug-eluting stents. The patent issue did not involve the stent itself. The company plans to appeal the ruling and stated, "Given current inventory and expanding manufacturing capabilities elsewhere, Cordis Corporation does not expect a significant impact on its ability to supply the ex-U.S. marketplace for these products."

May 31, 2005
DES Prove Popular, But Docs Say Improvements Still Needed
Reporting on a Guidant-sponsored symposium at this year's EuroPCR course in Paris, Medical Device Daily gives an interesting picture of the current and near-future state of drug-eluting stents. Dr. Renu Virmani, a frequent critic of drug-eluting-stent-mania, found Guidant's Xience V everolimus stent superior in many ways.
(source: Holland Johnson, BioWorld Today Online)

May 25, 2005
Abbott Launches TriMaxx Coronary Stent and Five New Products for Vascular Intervention at Paris Course on Revascularization
The company announced that it has launched its next-generation coronary stent, TriMaxx™, the platform for its much-anticipated investigational drug-eluting stent, ZoMaxx™, in Europe today. In addition, Abbott also lauvhed five other vascular products. Chip Hance, president of Abbott Vascular states, "Physicians in Europe will appreciate TriMaxx' unique stainless steel and tantalum tri-layer design. Along with the introduction of TriMaxx, the European launch of five additional products demonstrates our continuing commitment to deliver high-performing technology that can be relied upon by physicians to build their interventional practices. All of our products, including our flagship StarClose™ Vascular Closure System, are developed with the core intention of improving patient outcomes and enhancing quality of life."
(source: Abbott Laboratories)

May 24, 2005
Conor Medsystems Announces Positive Twelve-Month Follow-Up Data From EuroSTAR Pivotal Study
This was a relatively small trial reported at the EuroPCR course, but the results are interesting. At twelve-month follow-up, the target lesion revascularization (TLR) rate was 2.9 percent and the rate of cumulative major adverse cardiac events (MACE) was 7.6 percent. There were no reported cases of stent thrombosis between the cessation of anti-platelet therapy at six months and twelve-month follow-up. The principal investigators for this study are Dr. Keith Dawkins from Southampton, UK and Dr. Antonio Columbo of Milan, well-known to all in the interventional community.
(source: Conor Medsystems, Inc.)

May 23, 2005
FDA Approves 12-Month Shelf Life for Taxus® Stent System
In a press release, the company announced today that the FDA has extended the approved shelf-life of its Taxus drug-eluting stent from the current 9 months to 12 -- it is currently 18 months outside the U.S. The company also notes that "the new TAXUS U.S. shelf life is longer than any competing product" -- by "any" the company means the only other competing product, i.e. the Cypher stent, made by Cordis / Johnson & Johnson. It will be interesting to see if this announcement is followed by a similar extension for the Cypher -- this occurred last month when the FDA approved both products for immediate MRI scanning after stenting within a two week period. The current shelf life for the Cypher stent is 3 months in the U.S. and 5 months outside the U.S..
(source: Boston Scientific Corporation)

May 17, 2005
Abbott Enrolls First Patient in Pivotal Zomaxx™ Drug-Eluting Stent Clinical Trial
The company has enrolled its first patient in the North American phase of its Zomaxx II trial, approved by the FDA in April. This new stent uses a drug coating somewhat different than the current "limus" and paclitaxel varieties -- a coating discovered and produced by Abbott (other stents use drugs licensed from third parties). Jeffrey W. Moses, M.D., who performed the first interventional procedure in the ZOMAXX II trial, states in this press release, "I found the ZoMaxx stent to be highly deliverable. It performed superbly during the procedure and appears to have enough flexibility to make it a compelling candidate for use in certain difficult-to-treat cases.... ZoMaxx is also clearly visible under x-ray fluoroscopy, contributing to its ease of use and the ability to see its excellent scaffolding during and after stent implantation procedures."
(source: Abbott Laboratories)

May 17, 2005
Gamble wins big at Boston Scientific
In a "local firm makes good" story, the company moved into the top spot on the Boston Globe 100 ranking of the best-performing Massachusetts companies -- it was the first life sciences company to do so. The article provides some historical perspective on how Boston Scientific initially could not afford the $40 million asking price to purchase the company that made the first cardiac stent in 1993 -- Johnson & Johnson bought Cordis and is now Boston Scientific's chief competitor. But the big story is how Boston Scientific successfully dealt with a manufacturing defect that caused the recall of virtually all its Taxus stents last summer (read our feature on the recall) and increased sales by over $2 billion last year.
(source: Ross Kerber, Boston Globe)

May 10, 2005
Conor Medsystems Receives CE Mark Approval for UniStar™ Cobalt Chromium Stent
The company today announced that its UniStar™ cobalt chromium bare-metal coronary stent received CE Mark approval in the European Community for the treatment of de novo coronary artery lesions. Conor also announced today that the company has received ISO certification of its facility in Athlone, Ireland for the commercial manufacturing of its proprietary coronary stents including the UniStar stent and the CoStar™ cobalt chromium paclitaxel-eluting coronary stent, which it hopes to have approved later this year.
(source: Conor Medsystems, Inc.)

May 5, 2005
Guidant Receives Approval to Begin U.S. Drug Eluting Stent Trial
In it press release, Guidant states that the "SPIRIT III is a large-scale pivotal clinical trial evaluating the safety and efficacy of Guidant's drug eluting stent system for the treatment of coronary artery disease. This prospective, randomized, single-blind trial compares XIENCE™ V, an everolimus eluting coronary stent system utilizing Guidant's cobalt chromium MULTI-LINK VISION® Coronary Stent System platform, versus the TAXUS® Express 2™ Paclitaxel Eluting Coronary Stent System. Results of the SPIRIT III trial may be used to obtain FDA approval for XIENCE(TM) V for the treatment of coronary artery disease.
(source: Guidant Corporation)

May 4, 2005
Cook to Begin First International Trial of a Paclitaxel-Eluting Stent for Peripheral Artery Disease
With a U.S. trial already underway, Cook Group will expand its efforts to bring the world's first paclitaxel-eluting stent for peripheral artery disease (PAD) to market by launching an international clinical trial, company officials reported today. The global clinical investigation of Cook's Zilver® PTX™ Drug-Eluting Stent will enroll 760 patients at up to 50 investigational sites in Europe, Asia, Australia and Canada.
(source: Cook Incorporated)

May 3-4, 2005
Coated stents' blood-clot risk may be higher than thought
Another article on the JAMA article (below)
(source: Boston Globe)
Incidence, Predictors, and Outcome of Thrombosis After Successful Implantation of Drug-Eluting Stents
Abstract of the article published in the May 4 issue of JAMA. The authors' conclusion is "The cumulative incidence of stent thrombosis 9 months after successful drug-eluting stent implantation in consecutive "real-world" patients was substantially higher than the rate reported in clinical trials. Premature antiplatelet therapy discontinuation, renal failure, bifurcation lesions, diabetes, and low ejection fraction were identified as predictors of thrombotic events."
(source: Journal of the American Medical Association)
Drug-Coated Stents Show Shortfalls
An good article with a somewhat misleading headline -- thrombosis, or blood-clotting, always has been a concern in the use of drug-eluting stents. That is why blood-thinning drugs, such as Plavix (clopidogrel) or ticlopidine, and aspirin are routinely prescribed for patients who have had drug-eluting stent placement for at least 3 months, and up to a year in some practices. So a study published in JAMA (link to the abstract is listed above) of 2,229 patients conducted in 3 German and Italian hospitals is generating headlines because the "real world" thrombosis rate is double what has been observed in clinical trials for these devices -- "double" means 1.3% in this study, as contrasted with 0.4-0.6% in clinical trials where one would assume post-procedural compliance was higher. For a perspective on this news, read "Voice in the Ear" -- our Editor's blog.
(source: Ed Edelson, HealthDay)
Drug-eluting stents: some bare facts
A "must read": in an October 2004 letter, commenting on a study of late-stent-thrombosis, Dr. Eisenberg, of Montreal, Quebec, Canada discusses the whole topic of stent thrombosis in the era of drug-eluting stents -- an excellent overview which puts today's headlines into perspective -- one of the major problems, as reported in the JAMA study from Milan, is the premature discontinuation of antiplatelet therapy in drug-eluting stent patients. For those whose do not have a subscription to The Lancet, this article from Journal Club has a good summary.
(source: Mark J Eisenberg MD, The Lancet -- requires subscription to read)

April 20, 2005
Boston Scientific Announces Publication of Six TAXUS IV Articles in Prestigious Journal of American College of Cardiology
A half-dozen studies from TAXUS IV data are reported in today's JACC, ranging in subject matter from gender difference to treatment of diabetics.
(source: Boston Scientific Corporation)

April 20, 2005
CYPHER® Sirolimus-Eluting Coronary Stent Receives FDA Approval for MRI Scans Immediately Following Implantation
Following their approval two weeks ago for the Taxus stent, the FDA is now satisfied that Johnson & Johnson's Cypher is also safe for immediate MRI imaging. Patients no longer have to wait two months before undergoing an MRI test. This announcement means that both drug-eluting stents available in the U.S. are safe for immedtae MRI.
(source: Cordis Corporation)

April 14, 2005
Boston Scientific Announces FDA Approval and Launch of Liberte™ Coronary Stent System
In a significant step towards approval of what will almost certainly be the first second-generation drug-eluting stent in the U.S. next year, the company announced today that the F.D.A. has approved the Liberte stent -- the bare metal version -- which serves as the platform for the TAXUS Liberte stent, already available in 18 international markets. Boston scientific plans to launch the new drug-eluting stent in Europe later this year, and hopes for a mid-2006 approval in the U.S. The FDA approval for the Liberte stent can be found here.
(source: Boston Scientific Corporation)

April 12, 2005
Boston Scientific Announces Start of Enrollment in Groundbreaking Clinical Trial Comparing Drug-Eluting Stents to Cardiac Surgery
The company announced that a major clinical trial comparing the Taxus paclitaxel-eluting stent with bypass surgery (CABG) has begun with the first patient enrolled at Institut Hospitalier Jacques Cartier in Massy, France by Dr. Marie-Claude Morice (who was principal investigator for Johnson & Johnson's REALITY trial). The SYNTAX Trial will enroll over 4,200 patients at up to 90 sites in Europe and the United States and will study patients with triple-vessel and left main disease, the most complex patient set studied in such a trial. As Dr. Morice stated, ""The drug-eluting stent revolution has led us to the point where a randomized comparison of the TAXUS system with surgery in the highest-risk patients is critical....The results of this study may profoundly change the practice of medicine." Principal investigators for the study are Professor Friedrich Mohr, M.D., Program Director of the Heart Center/Cardiothoracic Surgery, University of Leipzig, Germany and Professor Patrick Serruys, M.D., Ph.D., Chief of Interventional Cardiology, Thoraxcenter-Erasmus University Rotterdam, The Netherlands.
(source: Boston Scientific Corporation)

April 12, 2005
Medtronic Announces First Patient Enrollment in the ENDEAVOR IV Clinical Trial
Medtronic announces the final phase of its ENDEAVOR Clinical Program aimed at gathering clinical data to secure approval for its drug-eluting stent. The co-principal investigators of the ENDEAVOR IV trial are Martin B. Leon, M.D. Columbia University Hospital, New York, and David M. Kandzari, M.D., Duke University Medical Center, Durham, N.C. Endeavor IV compares the Medtronic stent to the Taxus; Endeavor III is a comparison with the Cypher and its results are expected to be presented at this year's TCT.
(source: Medtronic, Inc.)

April 10, 2005
Guidant jobs may be at risk in merger deal
There's talk that the impending merger with Johnson & Johnson may cause Guidant facilities in California to cut staff.
(source: Laura Cutland, Silicon Valley/San Jose Business Journal, courtesy MSNBC)

April 7, 2005
Abbott Receives FDA Approval to Begin ZOMAXX II U.S. Drug-Eluting Coronary Stent Trial
Looking to an anticipated U.S. approval for their drug-eluting stent in the second half of 2007, Abbott is beginning enrollment of 1,670 coronary artery disease patients in up to 80 centers. The press release states: "The trial will compare clinical outcomes in patients who are treated with Abbott's investigational ZoMaxx drug–eluting coronary stent with patients who receive Boston Scientific's Taxus™ Express2™ drug–eluting stent. The primary endpoint of ZOMAXX II is 9–month ischemia–driven target vessel revascularization, a clinical measure of the need to conduct another intervention (stent, brachytherapy or surgery) to reopen a vessel previously treated with a stent."
(source: Abbott Laboratories)

April 6, 2005
Boston Scientific First to Market with Full Range of Large Vessel Drug-Eluting Stent System Sizes
The company announced today that it has received CE Mark for three large vessel sizes (4.0mm, 4.5mm and 5.0mm) of its TAXUS stent in Europe and other international markets.
(source: Boston Scientific Corporation)

April 5, 2005
Boston Scientific's TAXUS® Express2™ Paclitaxel-Eluting Stent System First Drug-Eluting Stent to Receive FDA Approval Allowing Immediate MRI Exams
In good news for patients, the FDA has approved Boston Scientific's Taxus drug-eluting stent, as well as its bare metal uncoated version, the Express2, allowing MRI scans immediately after implantation. MRI is utilized in many patients who also have had stents placed, but previously they had been advised to wait up to two months between the stenting and MRI.
(source: Boston Scientific Corporation)

March 23, 2005
First U.S. Drug-Eluting Stent Trial To Treat Peripheral Arterial Disease Enrolls First Patient At Stanford University Medical Center
(source: Cook Incorporated)
A trial to test if a paclitaxel-coated drug-eluting stent can help solve the problem of peripheral (leg) artery disease (PAD) has begun with the first patient enrolled at Stanford. The Zilver PTX trial is being conducted initially in 10 U.S. medical facilities and will enroll 60 patients, with an expanded trial likely pending further FDA review.

March 23, 2005
Conor Medsystems Receives Conditional IDE Approval From the FDA to Begin COSTAR II Pivotal Clinical Trial
The company has gained FDA approval to begin a clinical trial of their unique stent for the treatment of restenosis. The CoStar™ stent is made of cobalt chromium, not stainless steel, and contains small reservoirs which contain the drug paclitaxel, the same drug that is used in the polymer coating of Boston Scientific's Taxus stent, against which it will be compared. The results of this clinical trial will be interesting in that the same drug is being used -- just being delivered in a different way.
(source: Conor Medsystems, Inc.)

March 15, 2005
Conor Medsystems Signs Multi-Drug Agreement to Develop Next-Generation Reservoir-Based Drug-Eluting Stents
Conor MedSystems, a developer of a unique drug-reservoir-based stent has entered into an agreement with Novartis Pharma AG to look at three different drugs to evaluate their efficacy in preventing restenosis.
(source: Conor Medsystems, Inc.)

March 6, 2005
Clinical Results Of Pivotal Trial Show Endeavor™ Drug Eluting Stent Provides Significant Treatment Effect In Patients With Coronary Artery Disease
The final ENDEAVOR II clinical data was very good and will move Medtronic's entry into the drug-eluting stent arena forward. Dr. William Wijns of Belgium and Co-Principal Investigator of the trial stated, "Overall the clinical results are impressive and show that more than 95 percent of the patients who received an Endeavor stent in the trial required no further treatment or revascularization at the original treatment site at the nine month assessment period."
(source: Medtronic, Inc.)

March 5, 2005
Conor Medsystems Announces Positive Angiographic and Clinical Results for EuroSTAR Drug-Eluting Stent Trial
The company today reported six-month follow-up angiographic and clinical data from their EuroSTAR study evaluating its CoStar™ cobalt chromium paclitaxel-eluting stent in a complex patient cohort. The in-stent binary restenosis rate was 3.4 percent and the in-stent late loss was 0.26 millimeters. The in-segment binary restenosis rate was 4.7 percent and the in-segment late loss was 0.07 millimeters. As previously reported, the target lesion revascularization (TLR) rate was 1.7 percent and the rate of cumulative major adverse cardiac events (MACE) was 4.8 percent.
(source: Conor Medsystems, Inc.)

March 4, 2005
Boston Scientific Announces Completion of Acquisition of Advanced Stent Technologies, Inc.
AST has designed stent systems that treat bifurcations, the place where a single blood vessel branches into two. These have historically been difficult to treat and have had greater chance of recurrence. The company hopes that this new technology combined with the Taxus paclitaxel polymer might change those outcomes.
(source: Boston Scientific Corporation)

March 3, 2005
Heart Meeting To Focus On J&J Stent Vs Boston Scientific
An overview from DowJones on the various trials and presentations coming up this weekend at the annual ACC meeting, which the author states "should be the most important meeting on drug-eluting stents since 2003."
(source: Daniel Rosenberg, Dow Jones Newswire)

March 3, 2005
Medtronic Announces Key Activities At American College Of Cardiology Scientific Session
The company announces the various clinical trial presentations and corollary activities around the upcoming ACC. Key sessions include data on Medtronic's Endeavor II trial for their drug-eluting stent.
(source: Medtronic, Inc.)

March 3, 2005
Boston Scientific to Announce Results from its TAXUS V Drug-Eluting Stent Clinical Trial, Studying Most Challenging Lesions and Highest-Risk Patients
Company press release lists the scheduled presentations and symposia they are sponsoring around the upcoming American College of Cardiology meeting in Orlando, Florida. The TAXUS V studies will show 9-month data from the latest TAXUS trial which, according to the company, looked at "higher-risk patient population, including patients with small vessels, large vessels and long lesions requiring multiple overlapping stents -- the most challenging lesions and highest-risk patients ever studied in a randomized controlled drug-eluting stent trial in the U.S."
(source: Boston Scientific Corporation)

March 2, 2005
Boston Scientific fires at J&J study
Paul LaViolette, COO of Boston Scientific, commenting on the upcoming REALITY trial results (to be presented on Sunday morning) of J&J's CYPHER stent vs. Boston Scientific's TAXUS, says, ''It was designed to show Cypher's superiority over Taxus, and it will therefore fail...."
(source: Ross Kerber, Boston Globe)

February 24, 2005
CYPHER® Sirolimus-Eluting Coronary Stent to Be Featured in Late-Breaking Clinical Trial Presentations at 2005 American College of Cardiology Scientific Session
A company press releases states that: "Four late-breaking presentations on Sunday, March 6 will examine the CYPHER® Stent's clinical performance across a variety of patient populations. Among the presentations at the international medical conference will be results from the REALITY Trial, a randomized prospective global study that examines the CYPHER® Stent versus the Taxus Stent; the ARTS-II trial, which details long-term results of a multi-center prospective, non-randomized study of multi-vessel stenting; the SIRTAX trial, an independent randomized comparison of the CYPHER® Stent with Taxus Stent for coronary revascularization; and the ISAR-DIABETES trial, an independent German study designed to test the safety and efficacy of the CYPHER® Stent and the Taxus Stent in the treatment of patients with diabetes."
(source: Cordis Corporation)

February 24, 2005
Reuters Summit-All Eyes On Medtronic in Stent Wars
Results from Medtronic's drug-eluting stent trial, Endeavor II, will be presented along with those of a number of trials at the upcoming American College of Cardiology Annual Meeting (ACC '05).
(source: Debra Sherman, Reuters)

February 23, 2005
Boston Scientific Announces Start of Enrollment in World's Largest Drug-Eluting Stent Registry
In a press release, the company states that the "TAXUS OLYMPIC registry plans to enroll more than 30,000 patients at more than 600 centers in the United States, Europe and other international locations. The registry is designed to collect and analyze 'real-world' clinical outcomes data for the TAXUS® Liberte™ paclitaxel-eluting stent system in the treatment of patients with coronary artery disease."
(source: Boston Scientific Corporation)

February 23, 2005
Reuters Summit-Boston Scientific sees good stent trial
Speaking to the Reuters Medical Devices Summit, Paul LaViolette, Chief Operating Officer of Boston Scientific, expressed confidence that two important clinical trials, whose results are to be announced at the upcoming ACC '05, will show favorable results for the company: REALITY, which compares J&J's CYPHER stent to Boston Scientific's TAXUS (the trial is sponsored by J&J) and TAXUS V, which studies very sick patients who have been treated with the TAXUS stent.
(source: Julie Steenhuysen, Reuters)

February 23, 2005
Reuters Summit-Abbott Sees Stent in '06 Outside U.S.
Richard Gonzalez, Chief Operating Officer of Abbott's medical products group, told the Reuters Medical Devices Summit that the company is confident that their drug-coated stent should become available outside the U.S. next year and reach the U.S. market by 2007.
(source: Julie Steenhuysen, Reuters)

February 22, 2005
Boston Scientific Announces Completion of Enrollment in Pivotal Clinical Trial For Next-Generation Paclitaxel-Eluting Coronary Stent System
The company announced that it has completed enrollment of 872 patients in the ATLAS trial, designed to evaluate the safety and efficacy of a slow-dose formulation of the new Taxus® Liberte™ thin-strutted stent. Boston Scientific is planning to launch this second-generation drug-eluting stent in Europe later this year.
(source: Boston Scientific Corporation)

February 21, 2005
Coated Stents Superior Over the Long Term: Study finds advantages over bare-metal stents after three years
A report on study appearing in Circulation from Clinique Pasteur in Toulouse, France, looking at data from the RAVEL clinical trial
(source: Ed Edelson, HealthDay)

February 18, 2005
Conor Countersues Angiotech Over Patent
Keeping in the news (see yesterday's press release below) Conor has filed a lawsuit in Britain against Angiotech Pharmaceuticals Inc.'s patented paclitaxel technology). This comes two weeks after Angiotech and Boston Scientific Corp. sued Conor in the Netherlands for alleged patent infringement. In their press release, Angiotech states that they, "...will pursue and defend against, to the fullest, any and all actions of Conor Medsystems respecting Angiotech's extensive patent portfolio and pioneering technology."
(source: Associated Press)

February 17, 2005
Conor Medsystems Announces Positive Six-Month Follow-Up Data from EuroSTAR Pivotal Study
In its press release, Conor Medsystems says that a study presented at the annual Joint Interventional Meeting in Rome, Italy supports the safety and efficacy of the company's CoStar(TM) Cobalt Chromium Paclitaxel-Eluting Coronary Stent
(source: Conor Medsystems, Inc.)

February 14, 2005
Stories of Survival and Hope Mark the One Million Patient Milestone For the CYPHER® Sirolimus-eluting Coronary Stent
Cordis announced today that the company had passed a milestone: more than one million patients have now received the CYPHER® Sirolimus-eluting Coronary Stent worldwide; that comes out to around 1.5 million CYPHER stents. The press release profiles two patients who have resumed normal active lifestyles and also quotes Martin Leon, M.D. of Columbia Presbyterian Hospital in New York City, the first U.S. cardiologist to use the CYPHER: "This medical technology of drug-eluting stents has introduced a new era in cardiology where patients can be treated less invasively and have a better chance of avoiding a repeat cardiac procedure."
(source: Cordis Corporation)

February 3, 2005
Caution Against Using Certain Drugs to Unclog Heart Arteries
This report on a study by Dartmouth Medical School cardiology researchers discusses the discoveries of a dual mechanism of why arteries reclose after stenting, and what implications their research might have in the development of drug-eluting stents.
(source: Medical News Today)

February 2, 2005
Boston Scientific maps out post-Taxus strategy
Boston Scientific seeks new markets
Two business views (one from Minneapolis, the second from Boston) discussing presentations made in yesterday's analysts meeting and what's in the medical device pipeline at Boston Scientific
(source: Janet Moore, Star Tribune (free registration required to read) / Ross Kerber, Boston Globe )

February 1, 2005
Stent Sales Boost Boston Scientific
The company reports that its fourth-quarter profit more than doubled to $297 million, as a result of its TAXUS drug-eluting stent sales.
(source: Mark Jewell, Associated Press)

February 1, 2005
Stent Maker's Hearty Returns
A positive take from The Fool on today's quarterly report by Boston Scientific and a look to the future competition.
(source: Stephen D. Simpson, Motley Fool)

January 31, 2005
Price fight is looming over stents: Johnson & Johnson takes on rival Boston Scientific
J&J seems to have cut its price on drug-eluting stents. This article quotes Dr. Joe Kozina, a cardiologist at Mercy General Hospital in Sacramento, "...he's been offered the lower prices by Johnson & Johnson salespeople. But he hasn't stopped using mostly Taxus stents, saying they are easier to place in blood vessels. 'Pricing makes no difference if I can't get the stent into the patient...'"
(source: Ross Kerber, Boston Globe)

January 31, 2005
Physician Feedback Is Extremely Positive as Boston Scientific Completes Initial Launch of TAXUS® Liberte™ Paclitaxel-Eluting Stent System
Maurice Buchbinder, M.D., of the Foundation for Cardiovascular Medicine in San Diego used the new 2nd-generation drug-eluting stent during a recent live demonstration course in Singapore and he comments, "Despite somewhat challenging anatomy, the TAXUS Liberte stent system performed very nicely, crossing the lesions with ease and conforming to the anatomy very well. The angiographic results were superb."
(source: Boston Scientific Corporation)

January 27, 2005
Is overdilatation of 3.0 mm sirolimus-eluting stent associated with a higher restenosis rate?
Answer: No. A study from Antonio Colombo's group in Milan addressed the questions raised in the fall of 2003 as to whether there might be a negative effect to over-expanding a 3.0mm Cypher stent to 3.5 or 4.0mm using a balloon and found no increase of restenosis. The abstract ends, "These data should lessen concern that overdilation may dilute the beneficial effects of Sirolimus-Eluting Stents."
(source: Catheterization and Cardiovascular Interventions -- abstract)

January 27, 2005
ARIAD Announces Collaboration with Medinol, Stent Technology Leader, to Develop AP23573 Drug-Delivery Stents
A triumverate of medical device manufacturers & a pharma firm specializing in new oncology drugs are teaming up to develop a new drug-eluting stent: ARIAD will supply its mTOR inhibitor, AP23573 to put on a stent developed by the privately-held Israeli firm Medinol, maker of the NIR® stents, with a polymer to be co-developed with W. L. Gore & Associates, a company with a long history in the vascular graft field.
(source: ARIAD Pharmaceuticals, Inc.)

January 19, 2005
Boston Scientific Announces Implantation of Millionth TAXUS® Express2™ Coronary Stent System
It's been an interesting week for Boston Scientific -- Monday saw the launch of its second-generation Liberte drug-eluting stent in 18 countries; today the company announced the 1,000,000th Taxus drug-eluting stent implanted. Gregg Stone, M.D. of Columbia University Medical Center, New York, a strong proponent of drug-eluting stents (see our interview) states, "This is a noteworthy milestone for Boston Scientific, for physicians and for patients. This product has truly revolutionized how we treat coronary artery disease and dramatically advanced the practice of interventional cardiology."
(source: Boston Scientific Corporation)

January 18, 2005
A prospective randomized comparison between paclitaxel and sirolimus stents in the real world of interventional cardiology: The TAXi Trial
A small study from the Clinique Cecil, Lausanne, Switzerland of 202 patients found no "real world" difference between sirolimus-based and paclitaxel-based drug-eluting stents (i.e. Cypher vs. Taxus). Outcomes and adverse events were similar -- both very good statistically.
(source: Journal of the American College of Cardiology -- free ACC registration required to read abstract)

January 17, 2005
Boston Scientific Is First to Market With Next-Generation Drug-Eluting Stent System
The new second generation Liberte drug-eluting stent is being launched today in 18 countries: Bahrain, Chile, Costa Rica, Dominican Republic, India, Indonesia, Kuwait, Lebanon, Malaysia, Panama, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Thailand, Turkey and Venezuela. The company describes the system, as follows: "The Liberte stent features the Veriflex™ stent design, a highly flexible cell geometry with thin struts and uniform cell distribution. This new platform offers improved deliverability and conformability in challenging anatomy. It also features the enhanced TrakTip™ catheter tip, mounted on the Maverick2™ delivery catheter, which provides better lesion crossability. In addition, TrakTip has a low lesion-entry profile, which further improves crossability."
(source: Boston Scientific Corporation)

January 16, 2005
Cordis sets sights on stent lead
Story about the current state of drug-eluting stents from the state of Florida, home of Cordis.
(source: Glenn Singer, Sun-Sentinel)

January 14, 2005
Johnson & Johnson Withdraws 300 Stents from Market
A manufacturing defect in a small number of drug-eluting Cypher stents has caused Johnson & Johnson to withdraw them from the market. A second article in the New York Times, "J.&J. Recalls 300 Heart Stents After Defects Are Found in 6" adds that these stents were made in the company's Puerto Rico facility which "was cited last year by the Food and Drug Administration for violations of manufacturing standards."
(source: Reuters / Barnaby J. Feder, New York Times)

January 6, 2005
Corautus Genetics Announces Publication of Gene Therapy Approach to Vascular Disease Using Stents in Circulation
In publication of preclinical results, the company states that delivery of VEGF-2 to blood vessels using drug-eluting stents was feasible and that this delivery led to accelerated growth of healthy endothelial cells while reducing pathological thickening of the artery ("neointima formation," or scarring) associated with restenosis. This could be very important since current drug-eluting stent medications work by suppressing endothelial growth in order to prevent restenosis. The studies build on a foundation of work started by the late Dr. Jeffrey Isner of St. Elizabeth's Medical Center in Boston (see our video clip).
(source: Corautus Genetics)

January 5, 2005
Medtronic loses patent case over heart stents
A federal judge ruled that two of Medtronic's stent devices used to treat clogged heart arteries infringed a patent held by rival Guidant, and that stents offered by Guidant and Boston Scientific did not infringe Medtronic's Boneau** patents (these patents were acquired when Medtronic purchased AVE about 10 years ago). **(Editor's note: everywhere in the media, reference is made to the "Boneau" patents, but the inventor is Michael D. Bonneau -- 2 N's in the name. Oddly enough, all but 2 of the patents filed with the U.S. Patent Office list a "Michael D. Boneau" as inventor. Did an "N" get dropped somewhere along the line?)
(source: Reuters)

January 2, 2005
Threat to health chiefs who ration cardiac treatment
Scotland's Minister for Health and Community Care Andy Kerr has warned a number of local health boards to approve use of drug-eluting stents -- some are not reimbursing for the expensive devices which have been shown to reduce restenosis. About 60% of English patients get the stents, while in Scotland only 5%, despite Greater Glasgow having Europe's second worst rate of heart disease.
(source: Liam McDougall, Sunday Herald)