FDA Approves First Absorbable Stent

Absorb GT1 BVS, an absorbable stent, approved for coronary artery disease

(RxWiki News) The US Food and Drug Administration (FDA) has approved the first absorbable stent for coronary artery disease (CAD).

That stent is the Absorb GT1 Bioresorbable Vascular Scaffold System (BVS). This stent is specifically designed for those who are candidates for angioplasty but prefer an absorbable stent instead of a permanent stent. An angioplasty is a procedure to restore blood flow through an artery.

The Absorb GT1 BVS is designed to absorb into the body in approximately three years. The fact that this stent can absorb into the body makes it an option for those who may not need a stent later on and removes the presence of a foreign object in the body. However, once the device is absorbed, four very small platinum markers will remain identifiable on the artery. This way, your doctor can identify where the stent was placed. 

Abbott Vascular's stent is also designed to release the medication everolimus (brand names Afinitor, Zortress) to prevent the formation of scar tissue around the stent. Preventing scar tissue from forming is important because scar tissue can narrow the artery again. 

CAD is the cause of about 370,000 deaths in the United States each year, according to the FDA. CAD develops when cholesterol builds up in the arteries, making them narrow and, in turn, decreasing blood flow to the heart. This can cause patients to feel chest pain, shortness of breath and tiredness. 

This stent is made up of biodegradable polymer called poly(L-lactide), which is similar to other medical devices that are absorbable, such as sutures. 

Possible adverse events with this stent and everolimus may include allergic reactions, bleeding, infection or irritation at the catheter insertion site or coronary artery complications. 

Absorb GT1 BVS is not to be placed in those with an allergy to everolimus or the materials used in this stent, such as poly(L-lactide), poly(D,L-lactide) or platinum, or those who have an allergy to contrast. This stent is not to be placed in those who are not candidates for angioplasty or those who cannot take long-term aspirin therapy with other blood-thinning medications.