An FDA advisory panel voted on March 15 to affirm that the benefits of the Absorb fully bioresorbable drug-eluting stent (Abbott Vascular) outweighed its risks and that the device was safe and effective as a treatment for coronary artery disease.
The FDA’s Circulatory System Devices Panel voted 9 to 0 in favor of the Absorb stent when asked if its benefits outweighed its risks. One member abstained from voting.
All 10 members said the stent was effective, while nine of the 10 voted in favor of its safety.
Abbott Vascular said in a news release that it expected the FDA to make a decision on the Absorb’s premarket approval by the end of 2016.
Researchers published the results of the prospective, randomized, single blind ABSORB III trial in the New England Journal of Medicine in October and concurrently presented the findings at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco in October.
They said the results were within the prespecified margin for noninferiority with regards to the primary end point of target lesion failure, which they defined as cardiac death, target-vessel MI or ischemia-driven target-lesion revascularization.
The study compared the Absorb stent with Abbott’s FDA-approved Xience metallic drug-eluting stent. After a year, 7.8 percent of patients who underwent PCI and received the Absorb stent had target lesion failure compared with 6.1 percent of patients who received the Xience.
The Absorb, which was approved in Europe in 2011, is made of a naturally dissolvable material and dissolves completely after two to three years, according to Abbott Vascular. Metal stents, meanwhile, are permanent implants.