An FDA panel last week threw its support behind Abbott’s drug-eluting coronary stent Absorb, which, if approved, would become the first fully bioresorbable vascular scaffold in the U.S.
The Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 9 to 0 — with one abstention — that the benefits of Absorb outweigh the risks. The panel also voted 9 to 1 that Absorb is safe and 10 to 0 that the device is effective.
The panel’s review was based in part on data from a trial of 2,000 people that showed the investigational device is comparable to Abbott’s Xience metallic drug-eluting stent.
If approved, Absorb will compete against Xience, Medtronic’s Resolute and Boston Scientific’s Synergy and Promus, says Lawrence Biegelsen, a senior analyst with Wells Fargo Securities.
He does not expect the product to capture significant market share, given its shortcomings, such as the difficulty to use, the numerically worse outcomes versus Xience and the higher rates of stent thrombosis.
In Europe, Absorb accounts for about 20 percent of Abbott’s total DES sales, or $143 million, in 2015. “In the U.S., we estimate Absorb will capture about 5 percent of the total DES market, although our estimate may prove conservative if the post-approval data and experience with Absorb improves,” Biegelsen adds.
Abbott submitted its premarket approval application for Absorb in mid-2015. Based on the panel’s recommendations, Biegelsen says he expects approval of the device in mid-2016. — Jonathon Shacat