FDA approves first absorbable stent for patients with coronary artery disease
The new product, called Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), sends a drug (everolimus) through the body to stop scar tissue from growing. The body gradually absorbs the drug and the stent within an estimated three years.
Approximately 370,000 people die from coronary heart disease each year within the U.S. alone. This health condition occurs when deposits that contain cholesterol are built up inside the coronary arteries, narrowing and reducing the heart’s blood flow.
Coronary heart disease symptoms include chest pain (angina), fatigue, shortness of breath or similar heart disease symptoms. Typically, health professionals treat this condition with angioplasty, a procedure that broadens the artery with a metal stent. Unfortunately, scar tissue gathers around the stent and narrows the arteries, known as restenosis.
With the FDA’s approval, the new product could change heart health for future patients with coronary heart disease.
“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,” Dr. Bram Zuckerman, director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health, said.