"Today's approval represents a significant step forward in the treatment of heart disease," says HHS Secretary Tommy Thompson, in a news release. "Patients who receive this device will need fewer repeat operations to unclog arteries, which can make a real difference in the quality of their lives."
Each year, 800,000 angioplasty procedures are performed to open clogged arteries to the heart. The stent -- a mesh-type tube that props open the vessel -- is inserted during the procedure.
However, in some 30% of patients, the artery becomes clogged again. It's a condition called restenosis, and it usually happens within a year. Another angioplasty or bypass surgery is required to re-open the artery again.
The new drug-coated stent, which contains the drug sirolimus, has been shown in clinical studies to significantly reduce the rate of new tissue that re-clogs the artery, according to the FDA. In studies conducted by the company, the stent reduced the rate of restenosis by more than two-thirds compared to patients with uncoated stents.
In the U.S. study of the device, 1,058 patients received either the drug-coated stent or an uncoated stent. After nine months, those with the coated stent had significantly lower rate of repeat procedures than patients with the uncoated stent. Also, 9% of patients with the coated stent had restenosis, compared to 36% of patients receiving the uncoated stent.
However, the FDA cautions that the device is only for certain heart patients. It has not been tested on patients who are having a heart attack or who had their blockage opened in a bypass procedure. Also, it is not designed for smaller arteries or longer blockages that require two stents.
Patients who receive the drug-coated stent will likely need to take certain kinds of blood-thinning drugs before having it implanted, the FDA adds.
SOURCE: News release, FDA.