Absorbable Stent Approved by FDA to Treat Coronary Heart Disease
Coronary heart disease is responsible for about 370,000 deaths each year in the U.S.
The Food and Drug Administration (FDA) has issued an approval for a product that has the potential to improve treatment for patients suffering from coronary artery disease.
The agency's approval is for the Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 BVS releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years.
Coronary heart disease is responsible for about 370,000 deaths each year in the U.S. , according to the National Heart, Lung, and Blood Institute. Doctors often treat the condition with a procedure called angioplasty to widen the artery using a metal stent. Scar tissue can form within the stent causing the artery to narrow again (restenosis). Drug-eluting stents temporarily release a drug, typically for a few months after stent placement, to combat the restenosis.
The Absorb GT1 BVS is manufactured from a biodegradable polymer called poly(L-lactide), which is similar to materials used in other types of absorbable medical devices, such as sutures. The device's absorption by the body gradually eliminates the presence of foreign material in the artery once the stent is no longer needed.
"The FDA's approval of the Absorb GT1 BVS offers a new treatment option for individuals who are candidates for angioplasty, but would prefer an absorbable device rather than a permanent metallic coronary stent," said Bram Zuckerman, in a written statement. Zuckerman is the director of the division of cardiovascular devices at the FDA's Center for Devices and Radiological Health.
In approving this product, the FDA evaluated data from a randomized trial of over 2,000 patients.
Possible adverse events that may be associated with the procedure to insert the Absorb GT1 BVS or with the Absorb GT1 BVS itself include allergic reactions to materials in the device or medications used during the procedure, allergic reaction to the drug everolimus, infection or irritation at the catheter insertion site, internal bleeding, the development of abnormal connections between arteries and veins, embolism, or other coronary artery complications that may require medical intervention and that could lead to death.
The Absorb GT1 BVS is manufactured by Abbott Vascular.