UPDATE: FDA panel OKs Abbott’s Absorb stent

UPDATED March 16 with comments from panel members. An FDA advisory panel recommended approval for the Absorb bioresorbable stent made by Abbott (NYSE:ABT). The Circulatory Devices panel voted 9-1 on safety, 10-0 on efficacy and 9-1 on the risk-benefit profile for the Absorb device, a coronary scaffold that’s designed to elute the drug everolimus before dissolving entirely over a period of months. The FDA is not bound to follow the recommendations of its advisory panel but often does. “I do believe this is a novel breakthrough technology for patients undergoing [percutaneous coronary intervention],” said panel member Dr. Ralph Brindis, of San Francisco’s Oakland Kaiser Medical Center, according to heartwire. “The holy grail is the idea of putting in a stent that stays open, elutes a drug to keep it open, and then disappears. People have been talking about this sort of thing for the past 2 decades as far as I’m aware, and I consider the technology potentially transformative,” added panel chairman Dr. Richard Page of the University of Wisconsin-Madison. Panelists and FDA representatives said they’re concerned about the safety of using Absorb in small vessels. Dr. Gregg Stone, principal investigator in Abbott’s Absorb III trial, told the panel that clinical experience in Europe has delivered a few key lessons on careful vessel sizing and routine post-dilation. “I think we’ve shown that there is reasonable effe...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Clearance Stents Abbott Source Type: news