A new advance in the treatment of coronary artery disease is one step closer to becoming a viable option for patients.
An independent panel of experts recently made the decision that the benefits of treatment with Absorb, a fully bioresorbable drug eluting coronary stent that is manufactured by pharmaceutical and medical device company Abbott, outweighed any possible adverse reactions. The panel was chosen by the U.S. Food and Drug Administration (FDA).
Typically, stents, which are used to open clogged arteries and keep them open, are made of metal and are permanent. Absorb, on the other hand, is fashioned from dissolvable materials and is reabsorbed completely by the body two to three years after implantation.
"Fully dissolvable devices represent a transformative advance in the treatment of coronary artery blockages," Charles Simonton, Abbott's chief medical officer, said. "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. That makes the Absorb stent a very attractive option for many patients who don't want permanent implants inside their arteries."
The panel also decided with a 9-1 vote that Absorb was a safe, effective way to treat coronary artery disease.
The panel arrived at its decision after reviewing data gleaned from several studies -- involving approximately 2,000 test subjects -- conducted on Absorb.
"In multiple randomized clinical trials, the Absorb bioresorbable vascular scaffold has demonstrated comparable outcomes to the leading permanent metallic stent," Gregg Stone, chairman of the Absorb clinical trial program, said. "As a first-in-kind device with novel properties, including complete dissolution and natural restoration of vessel function, this is a remarkable achievement."
The FDA is expected to make a decision on the pre-market approval application for Absorb later this year.
FDA panel deems Abbott's new dissolving stent safe, effective