Abbott wins positive FDA review for Absorb

Abbott (NYSE:ABT) said today that an independent FDA review panel voted 9 to 0, with one abstention, in support of its Absorb bioresorbable drug eluting coronary stent, determining that the benefits of the stent outweighed the risks.

The panel was voting on the device in relation to the standing pre-market approval for the Absorb device, a coronary scaffold that’s designed to elute the drug everolimus before dissolving entirely over a period of months.

In a separate vote, the panel also voted 9 to 1 in favor of there being a reasonable assurance that the device is safe, and voted 10 to 0 in favor of the device’s effectiveness, Abbott said.

“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 clinical trial program chair 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

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 is on track for Absorb approvals in China and Japan.

The post Abbott wins positive FDA review for Absorb appeared first on MassDevice.

from MassDevice http://ift.tt/1WoDuwo