First Drug-Eluting Stent Approved Since 2004

Food and Drug Administration (FDA) convened the Circulatory System Devices panel in 2006 to discuss evidence of the rare risk of blood clots occurring in patients who receive drug-eluting stents.

The Endeavor zotarolimus-eluting coronary stent is a tiny metal mesh tube coated with a small amount of a new drug, zotarolimus, developed only for use on a stent. The stent is crimped around a balloon and delivered via angioplasty. Once the stent is positioned, the balloon is inflated, expanding into the vessel wall where it will remain in place, and acting as a mechanical scaffold to keep the artery open. Slow release of zotarolimus over time prevents restenosis (re-narrowing of the artery when new tissue begins to form).

Studies from seven clinical trials showed that the Endeavor significantly reduced the number of major coronary events--heart attack, cardiac death and repeat procedures due to restenosis--when compared to a bare metal stents, and reduced restenosis rate by almost 50%. The number of adverse events experienced was similar to those that occurred in patients implanted with bare-metal stents and existing drug-eluting stents. Stent thrombosis rate was 0.4% at one year and 0.5% at two years, a rate similar to that for bare-metal stents. To further reduce clotting risk, patients receiving the Endeavor will need to take blood-thinning medication for at least six months after implantation and should consider continuing this regimen for 12 months, if they are not at an increased risk for bleeding complications. The Endeavor zotarolimus-eluting coronary stent is manufactured by Medtronic (Minneapolis, MN, USA).

"The Endeavor drug-eluting stent provides cardiologists with another option for treating the one million patients who undergo an angioplasty procedure every year to open their clogged coronary arteries,” said Daniel Schultz, M.D., director of the FDA center for devices and radiological health (Rockville, MD, USA). "This important approval is the result of a substantial amount of clinical evidence and a careful review by both FDA and its advisory committee.”

Before drug-eluting stents were available, about 15-30% of patients experienced restenosis within a year, requiring a repeat angioplasty. This number has dropped to 10% of patients since drug-eluting stents entered the U.S. market in 2003.


Related Links:
Medtronic
FDA Center for Devices and Radiological Health