Additional Relevant Details The FDA voted 9 to 0, with one abstention, that the benefits of Abbott's Absorb fully bioresorbable drug eluting coronary stent outweigh the risks.

The FDA advisory committee panel reviewed data from multiple studies of the Absorb dissolving stent, including ABSORB III, a company-sponsored U.S. clinical trial involving approximately 2,000 people that found the investigational device to be comparable to the market-leading metallic drug-eluting stent, Abbott's Xience drug eluting stent. At one year in ABSORB III, patients who received an Absorb dissolving stent had experienced comparable rates of specific adverse events—including heart disease-related death, heart attacks attributed to the stented artery and repeat procedures (collectively termed target lesion failure)—as compared to patients who received the Xience stent.