BETHESDA, Md., March 16 (UPI) -- The dissolving, drug-eluting stent Absorb was approved for use by a U.S. Food and Drug Administration panel on Tuesday, and the agency is expected to announce a final decision on approval of the device later this year.
The FDA panel voted nearly unanimously to approve Absorb for use with coronary artery disease patients who, according to manufacturer Abbott, will benefit from a temporary stent rather than a permanent metal one.
In clinical trials published last year in the New England Journal of Medicine and Journal of the American College of Cardiology, the drug-dispensing stent was shown to be as safe as permanent ones, but with the benefit of disappearance after the device has served its purpose.
"Fully dissolvable devices represent a transformative advance in the treatment of coronary artery blockages," Dr. Charles Simonton, chief medical officer for Abbott, said in a press release. "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.
The trials showed Absorb has rates of adverse health events such as heart attack or other repeat procedures related to the stent comparable to Xience, a permanent metal stent also manufactured by Abbott, according to the company's presentation to the FDA.
Abbot submitted the results of both studies to the FDA in 2015, showing in one study a 1.7 percent difference in adverse events, 7.8 percent for Absorb patients and 6.1 percent for Xience patients, and showing fewer events in the other, with 3.4 percent of Absorb patients having adverse events compared to 4.2 percent those receiving metal stents.
"As a first-in-kind device with novel properties, including complete dissolution and natural restoration of vessel function, this is a remarkable achievement," Dr. Gregg W. Stone, director, cardiovascular research and education at the Columbia University Medical Center and chairman of the clinical trial program for Absorb. "The available evidence supports an important role for this innovative device in the treatment of coronary artery disease."