by Robert Fay

The United States Food and Drug Administration (FDA) granted approval on February 1, 2008 to Medtronic to begin marketing its Endeavor zotarolimus-eluting coronary stent in the United States. Endeavor is the first drug-eluting stent (DES) that the agency has approved since 2004 and the first since the FDA's Circulatory Devices Panel convened in 2006 to discuss evidence regarding the risk of stent thrombosis among DES patients.

The FDA characterized the approval as "important," adding that it resulted from a "substantial amount of clinical evidence and a careful review by both the FDA and its advisory committee." The FDA cited evidence from 7 clinical trials that showed that the stent significantly reduced the number of major coronary events, such as myocardial infarction, cardiac death, and revascularization compared to bare metal stents (BMS), as well as reducing the restenosis rate by about half. In addition, the stent thrombosis rate was 0.4 percent at 1 year and 0.5 percent at 2 years, a rate similar to that of BMS. The FDA said that patients who receive the Endeavor stent will need antiplatelet therapy for at least 6 months and "should consider this regimen for 12 months if they are not at an increased risk for bleeding complications."

A second-generation stent, Endeavor combines zotarolimus, a nonproliferative agent, with a flexible platform that is designed to make delivery easier, especially through the coronary vasculature. Medtronic will continue to follow patients enrolled in 6 of the Endeavor trials for 5 years. In addition, the company will conduct a 2,000-patient U.S. post-approval study, which will be combined with 3,300 patients from a study conducted outside the United States, to assess the device's long-term safety and effectiveness and to look for rare adverse events, such as stent thrombosis. In addition, Medtronic will collect clinical data to identify the optimal duration of antiplatelet therapy. The company expects to ship 100,000 units to hospitals in the United States within the next 30 days.

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Sources: FDA News. FDA approves drug-eluting stent for clogged heart arteries. Accessed on February 4, 2008 at the FDA website.

Medtronic receives FDA approval for for Endeavor zotarolimus-eluting coronary stent system. Accessed on February 4, 2008 at the Medtronic website.

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