The U.S. Food and Drug Administration reported that sales of the Absorb GT1 stopped on September 14 and urged caution:
Although healthcare providers with available inventory may continue to implant the BVS, they should carefully consider its safety and effectiveness and only use it if they believe it is in the best interest of their patients.”
The Absorb GT1 Biosorbable Vascular Scaffold (BVS) is a coronary stent that was approved in July 2016. It is the first and only dissolvable stent that is approved for the treatment of coronary artery disease.
The Absorb BVS props open arteries that are narrowed or blocked, improving blood-flow to the heart. The Absorb BVS is made of a biodegradable polymer that is absorbed by the body within 3 years.
Unfortunately, it has been linked to increased risks of cardiovascular side effects, blood clots, heart attack, cardiac arrest, and death.
According to 2-year data from the ABSORB III clinical trial, the Absorb BVS device had an 11% risk of major cardiovascular events, compared to a 7.9% risk for the XIENCE® drug-eluting stent.
The clinical trial also linked the Absorb BVS to a 1.9% risk of blood clots (thrombosis) vs. a 0.8% risk with the XIENCE stent after 2 years.
In March 2017, the FDA warned healthcare providers about cardiovascular side effects. The FDA also advised healthcare providers to tell patients to seek emergency medical care if they are experiencing heart problems like irregular heartbeats, chest pain, or shortness of breath.