FDA Approves New Drug-Eluting Stent
FRIDAY Feb. 1, 2008 -- A new drug-coated stent has been approved the U.S. Food and Drug Administration to treat people with narrowed arteries that supply blood to the heart.
A stent is a wire mesh tube used to keep an artery propped open once it has been cleared of a blockage. The device is sometimes coated with a drug designed to help prevent an artery from reclogging, a process call restenosis. This device's new drug, zotarolimus, was developed only for use on a stent.
The Endeavor Zotarolimus-Eluting Coronary Stent is the first drug-eluting stent approved by the FDA since 2004, the agency said in a statement. Drug-coated stents have come under scrutiny recently over concerns that users may be at greater risk of a rare blood clot known as a stent thrombosis.
The maker of the Endeavor device, Minneapolis-based Medtronic Inc., conducted seven clinical trials of the device, in which the company said it was shown to significantly reduce the number of major coronary events -- including heart attack, cardiac death and surgical procedures to reopen stented arteries compared to a bare-metal stent.
Medtronic will follow patients who participated in clinical testing for five years, the FDA said. The company also will conduct a 2,000 patient post-approval study to evaluate the long-term safety and effectiveness of the device.
The FDA has more about this approval.
Posted: February 2008