Healthcare Industry News: stent thrombosis
News Release - February 1, 2008
Medtronic Receives FDA Approval for Endeavor(R) Zotarolimus-Eluting Coronary Stent SystemNew Drug-Coated Stent Offers Excellent Combination of Safety, Effectiveness and Deliverability
MINNEAPOLIS--(HSMN NewsFeed)--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. Source: Medtronic, Inc.
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.
Sustained and Consistent Reduction in the Need for Repeat Procedures
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.
Ultimately, the ENDEAVOR clinical program will enroll more than 22,500 patients followed to five years; approximately 16,630 of these patients will receive an Endeavor stent.
As a condition of FDA approval, Medtronic will continue its extensive post-market clinical program, which will now add sites in the United States to ensure that at least 5,000 patients are followed to a minimum of five years. In addition, Medtronic will collaborate with the FDA to conduct or participate in a study intended to identify the optimal duration of dual antiplatelet therapy following percutaneous intervention with the Endeavor drug-eluting stent.
More information for physicians and patients is available online at www.EndeavorStent.com.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Editor's Note: Interviews with physicians and Medtronic executives can be arranged by request. Broadcast-quality video, including soundbites and animation, is available through The News Market, www.thenewsmarket.com/medtronic, and also via satellite, Pathfire and hard copy by contacting Dan Schwartzberg at News Broadcast Network: 212-684-8910, ext. 220; email@example.com.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.
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