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U.S. Department of Health and Human Services

For Consumers

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FDA Approves Drug-Eluting Heart Stent

On Feb. 1, 2008, FDA announced approval of the first drug-eluting stent since 2004, for use in treating patients with narrowed coronary arteries, the blood vessels supplying the heart.

The Endeavor Zotarolimus-Eluting Coronary Stent, manufactured by Medtronic, Inc., of Minneapolis, is also the first drug-eluting stent to receive FDA approval since the agency held its Circulatory System Devices Panel in 2006. At this meeting, experts discussed evidence of the rare risk of blood clots occurring in patients who receive these stents.

How the Stent Works

Endeavor is a tiny metal mesh tube coated with a small amount of zotarolimus, a new drug developed only for use on a stent.

It is crimped around a balloon and delivered to the narrowed section of the coronary artery by a long thin catheter during a procedure known as an angioplasty. Once the stent is positioned, the balloon is inflated, expanding into the vessel wall where it will remain in place, acting as a mechanical scaffold to keep the artery open.

Slow release of zotarolimus over time prevents the artery from re-narrowing when new tissue begins to form.

Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological Health, says the Endeavor 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. “This important approval is the result of a substantial amount of clinical evidence and a careful review by both FDA and its advisory committee,” he says.

Warnings

Patients who are allergic to zotarolimus or to cobalt, nickel, chromium, or molybdenum, should not receive an Endeavor stent. Caution is also recommended for people who have had recent cardiac surgery and for women who are nursing or who may be pregnant.

Medtronic will continue to follow patients enrolled in six of the Endeavor clinical studies for five years. The company also 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.

Medtronic will also collect clinical data to identify the optimal duration of blood-thinning medication.

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This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: February 5, 2008