The FDA approved the Absorb fully bioresorbable drug-eluting stent (Abbott) on July 5 to treat patients with coronary artery disease.
The approval was based on results of the pivotal ABSORB III trial, which were published in the New England Journal of Medicine in October 2015 and simultaneously presented at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco.
The study showed that the Absorb stent was noninferior to Abbott’s FDA-approved Xience everolimus-eluting cobalt-chromium stent with regards to the primary endpoint of target lesion failure. The researchers defined target lesion failure as cardiac death, target-vessel MI or ischemia-drive target lesion revascularization.
In March, an FDA panel voted unanimously in favor of the Absorb stent’s efficacy and whether its benefits outweighed its risks. Nine of the 10 members of the panel also voted in favor of the stent’s safety profile.
The Absorb stent is made of a naturally dissolving material. Whereas metal stents are permanent implants, the Absorb stent typically disappears within three years, according to Abbott.
On April 28, Abbott agreed to acquire St. Jude Medical in a cash and stock transaction valued at approximately $25 billion. The deal is expected to close by the end of 2016.