Abbott announced that an independent panel of experts convened by the U.S. Food and Drug Administration (FDA) voted 9 to 0, with one abstention, that the benefits of Abbott's Absorb fully bioresorbable drug eluting coronary stent outweigh the risks.
Absorb is a first-of-its-kind bioresorbable device for the treatment of coronary artery disease, which affects millions of adults nationwide and remains a leading cause of death despite decades of therapeutic advances. While most stents are made of metal, Abbott's Absorb stent is made of a naturally dissolvable material. Absorb dissolves completely after 2 to 3 years, once it has done its job of keeping a clogged artery open and promoting healing of the artery. By contrast, metal stents are permanent implants that restrict vessel motion by caging the artery for the life of the individual treated.
The FDA panel also voted on the device's safety and efficacy as a treatment for coronary artery disease. On the question of whether there is reasonable assurance that the device is safe, the vote was 9 to 1 in favor. On the separate question of whether there is reasonable assurance that the device is efficacious, the vote was 10 to 0 in favor.
