Abbott pulls troubled Absorb stents from worldwide market

In an 82-word statement posted Friday, Sept. 8, Abbott Vascular announced it will stop selling its Absorb Bioresorbable Vascular Scaffold (BVS) in more than 100 countries citing low commercial sales. The halt includes both the Absorb and Absorb Gt1 Bioresorbable Vascular Scaffold Systems.

The first-generation Absorb BVS, the first and only fully dissolving heart stent available to date in the U.S., was approved by the U.S. Food and Drug Administration (FDA) in July 2016 to treat patients with coronary artery disease.

“We pioneered bioresorbable technology because we believe it offers patients the possibility of life without permanent metallic implants, and we will continue to work on a next-generation bioresorbable device,” Abbott said in a statement. “We’ll also continue to follow implanted patients in existing Absorb clinical trials to assess long-term outcomes after the scaffold has dissolved.”

This follows Abbott’s move in May to pull both stents from the European market, citing at that time they “will only be available for use in clinical registry setting at select sites/institutions.” In the company’s announcement to pull the stents from the market, Abbott said they were “working jointly with the European Regulatory Agencies” to address questions that included issues concerning stent thrombosis, duration of dual antiplatelet therapy (DAPT) after implantation, and implantation technique.

The Absorb BVS has been used to treat coronary artery disease but, unlike a metal stent, it dissolves completely after a patient’s artery is healed, allowing natural vessel movement to continue instead of being restricted by metal. To date, it has been used to treat more than 150,000 patients worldwide. It accounts for less than 1 percent of Abbott stent sales worldwide.