When Will Docs Reach for Medtronic?s Endeavor Stent?

The FDA just greenlighted Medtronic?s Endeavor drug-coated stent. That means there are now three manufacturers (Boston Scientific and J&J are the other two) fighting for a coated-stent market that?s been battered by safety concerns and accusations of over-use.

And before you start dividing that battered market by three, recall that Abbott?s probably going to get in on the action shortly, assuming the FDA follows everybody?s expectations and approves the Xience stent.

So how will the new stents compete against the old ones? Docs like to stay with what they know ? in this case, JNJ?s Cypher and Boston Scientific?s Taxus stent, Joseph DeGregorio, Director of Interventional Cardiology at Hackensack University Medical Center, told the Health Blog. But the word on the street is that the new stents are easier to put into tight spots, he said.

?A lot of the cases we do are not complicated and you can deliver any stent you want,? DeGregorio said. ?When you?ve had a proven product out there that you?re comfortable with, you?re gonna stick with that.?

The new stents may find a sizable foothold in the 20% to 30% of cases where doctors want to put the stent in some especially hard-to-get-to place, according to DeGregorio, who said he has financial ties to all of the stent makers. Because of factors such as the profile of the delivery package, the new stents from Abbott and Medtronic may work better in those cases.

?I have to get my hands on it,? he said of the Endeavor. ?I have to see what I think about the deliverability, which I?ve heard is better? [If] I couldn?t get in a Cypher or Taxus, I might use this stent.?


*** Doctors are "keng" kings also. Stent deliverability seems to be the top in their list of considering which DES to use. As long as their angioplasty job is done, any future problems is not the doctor's problems since they did their job already. Blame FDA or the medical device companies if the patients have late-thrombosis problems. All the DESs are approved for use anyway so the doctors will use whichever one that gives them the best "commission/loyalty program" package and ease of performing their surgery job.  

Medtronic Receives FDA Approval for Endeavor® Zotarolimus-Eluting Coronary Stent System

New Drug-Coated Stent Offers Excellent Combination of Safety, Effectiveness and Deliverability


MINNEAPOLIS ? Feb. 1, 2008 ?Marking a major development in the field of interventional cardiology, Medtronic, Inc. (NYSE: MDT), announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for the Endeavor® Zotarolimus-Eluting Coronary Stent System to be used in the treatment of coronary artery disease, which affects an estimated 13 million people in the United States and is the country?s leading cause of death.

Based on the most compelling and comprehensive body of scientific evidence submitted to the FDA for a drug-eluting stent, the approval gives U.S. cardiologists access to a new medical device for safely and effectively treating patients with narrowed coronary arteries. The Endeavor data encompasses the largest, most wide-ranging patient population submitted to the FDA in support of a drug-eluting stent, including more than 4,100 patients, followed up for as long as four years.  This extensive clinical research has shown that Endeavor provides a consistent and sustained reduction in the need for repeat procedures compared to a bare-metal stent, while also maintaining an excellent safety profile. The Endeavor stent is the first new drug-eluting stent approved by the FDA since 2004.

Enabling a minimally-invasive alternative to open-heart bypass surgery, stents are tiny wire mesh tubes used to prop open coronary arteries that have been cleared of blockages to restore blood flow to the heart muscle. Drug-eluting stents deliver medication to the artery wall to reduce the chance that the artery will narrow again and require a repeat procedure.

?Endeavor represents a true next-generation drug-eluting stent because of its unique design, which combines an advanced stent platform with the potent drug zotarolimus and a biocompatible polymer,? said Dr. Martin B. Leon, professor of medicine at Columbia University Medical Center in New York, cardiologist at New York-Presbyterian Hospital/Columbia University Medical Center, founder and chairman emeritus of the Cardiovascular Research Foundation, and principal investigator of the ENDEAVOR III and IV clinical trials. ?This device addresses an important need by demonstrating comparable clinical effectiveness to a first generation drug-eluting stent while also exhibiting a safety profile more typical of a bare-metal stent, long considered a benchmark for safety performance. In addition, it has the advantage of being exceptionally easy to deliver through the tortuous vessels of the coronary vasculature. For these reasons, the Endeavor stent will undoubtedly be a welcome addition to the practice of interventional cardiology in the United States.?

The U.S. market launch of the Endeavor stent begins immediately. ?We have been strengthening our field and manufacturing capabilities in anticipation of considerable demand for the Endeavor stent in the United States,? said Scott Ward, president of the CardioVascular business at Medtronic. ?We expect to ship 100,000 units to U.S. hospitals in the next 30 days to assure full availability of this next-generation technology.?

Extensive Long-Term Clinical Evidence of Safety and Effectiveness
The ENDEAVOR clinical program includes seven studies: three randomized controlled trials and four registries. Medtronic?s FDA submission included clinical data on more than 2,100 patients treated with the Endeavor stent, 1,287 of whom were studied to two years and 675 to three years. Highlights from the program include the following results:

Excellent Safety Profile Before and After One Year

• Presented at the FDA panel meeting in October, an analysis of pooled safety data from the ENDEAVOR clinical program reported a stent thrombosis rate for Endeavor patients of less than 1 percent within the first year and a remarkably low 0.08 percent from one year to three years post-implant. The same analysis revealed low cumulative rates of all safety measures out to three years of follow-up: stent thrombosis (0.7 percent); myocardial infarction (2.7 percent); and cardiac death (1.0 percent). Importantly, Endeavor has shown numerically fewer adverse events across all key safety measures versus a bare-metal stent. Of particular note from this analysis, just 3.5 percent of Endeavor patients experienced cardiac death or myocardial infarction through three years of follow-up, compared to 6.6 percent of patients who received a bare-metal stent.

• The Endeavor stent offers clinical effectiveness that is consistent with the current market-leading drug-eluting stent in the United States. ENDEAVOR IV, the randomized controlled trial comparing the Endeavor stent with Boston Scientific?s Taxus stent, met its primary endpoint, with a target vessel failure (TVF) rate in Endeavor patients of 6.6 percent at nine months. The TVF rate for Taxus patients at nine months was 7.2 percent. Importantly, Endeavor had similar efficacy compared to Taxus for all lesion subsets analyzed, and there were no statistically significant differences in target lesion revascularization (TLR), the clinical measure for repeat procedures.

• Compared to a bare-metal stent in the ENDEAVOR II clinical trial, the Endeavor stent has been shown to reduce the need for repeat procedures by more than 61 percent at nine months. This treatment effect is sustained, with only 7.3 percent of Endeavor patients in this randomized controlled trial requiring a repeat procedure out to three years of follow-up.

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