February 1, 2008 - Medtronic Inc. has received approval from the FDA for the Endeavor Zotarolimus-Eluting Coronary Stent System to be used in the treatment of coronary artery disease.
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 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.
The U.S. market launch of the Endeavor stent begins immediately. "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," said Scott Ward, president of the CardioVascular business at Medtronic.
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 Scientificï¿½s 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.
For more information: www.EndeavorStent.com and www.medtronic.com