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.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.