UPDATED March 16 with comments from panel members.
The Circulatory Devices panel voted 9-1 on safety, 10-0 on efficacy and 9-0, with one abstention, 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 effectiveness; we just have to ensure that it is implanted in the right patients,” said Stone, of New York City’s Columbia University Medical Center.
“Fully dissolvable devices represent a transformative advance in the treatment of coronary artery blockages. The unique benefit of Absorb is that it opens the blockage like a metallic stent, but then goes away over time, allowing the artery to return to a more natural state. That makes the Absorb stent a very attractive option for many patients who don’t want permanent implants inside their arteries for the rest of their lives. We thank the members of the panel for their thorough review of the data, and we look forward to continuing discussions with the FDA on our submission for approval of this device in the U.S.,” Abbot vascular biz veep of medical affairs Dr. Charles Simonton said in a press release.
The decision was reached after the FDA advisory committee panel reviewed data from multiple studies of the Absorb stent, including the 2,000-patient Absorb III clinical trial that reported outcomes similar to Abbott’s Xience drug eluting stent.
“In multiple randomized clinical trials, the Absorb bioresorbable vascular scaffold has demonstrated comparable outcomes to the leading permanent metallic stent. As a first-in-kind device with novel properties, including complete dissolution and natural restoration of vessel function, this is a remarkable achievement. The available evidence supports an important role for this innovative device in the treatment of coronary artery disease,” Absorb III principal investigator Dr. Gregg Stone said in prepared remarks.
The company said it expects a decision from the FDA on its PMA some time later this year. The proposed indication for Absorb GT1 is improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of up to 24mm in blood vessel diameters of 2.5mm to 3.75mm.
If approved in the U.S., Absorb would compete with Medtronic‘s (NYSE:MDT) Resolute stent and Boston Scientific‘s (NYSE:BSX) Synergy and Promus stents. Synergy’s polymer coating used to deliver a drug disappears over time, leaving a bare-metal stent in place.
Wells Fargo analysts have estimated that Absorb could initially capture about 5% of the total drug-eluting stent market.
The Absorb GT1 landed CE Mark approval in the European Union in May 2015. The Absorb stent met the primary endpoint in a Phase III pivotal trial, researchers announced last October at the annual Transcatheter Cardiovascular Therapeutics conference.
Abbott has said it’s on track for Absorb approvals in China and Japan.
ABT shares dipped -1.5% to close at $39.90 March 15.
Material from Reuters was used in this report.