First-of-its-Kind Heart Stent Gets Thumbs Up from FDA Panel
An FDA Advisory Committee voted 9 to 0 in favor of Abbott's Absorb fully bioresorbable drug-eluting coronary stent, with one abstention. Absorb stent is a first-of-its-kind fully dissolving heart stent for the treatment of coronary artery disease.
Unlike metal stents which are permanent implants that restrict vessel motion by caging the artery for the life of the patient, Absorb stent is made of a naturally dissolvable material which dissolves completely after 2 to 3 years. "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 for the rest of their lives," said Charles Simonton, M.D., FACC, FSCAI, chief medical officer and divisional vice president of medical affairs for Abbott's vascular business.
After reviewing data from multiple studies, including ABSORB III, a company-sponsored U.S. clinical trial which included nearly 2000 patients, the FDA committee concluded that the investigational device is comparable to the metal drug-eluting stent, Xience (also from Abbott). Compared to patients who received the Xience stent, patients in the ABSORB III trial who received an Absorb dissolving stent had experienced comparable rates of adverse events including heart disease-related death, heart attacks attributed to the stented artery and repeat procedures, after one year.
"In multiple randomized clinical trials, the Absorb bioresorbable vascular scaffold has demonstrated comparable outcomes to the leading permanent metallic stent. As a first-in-kind device with novel properties, including complete dissolution and natural restoration of vessel function, this is a remarkable achievement," said Gregg W. Stone, M.D., FACC, FSCAI, director, cardiovascular research and education, Center for Interventional Vascular Therapy, Columbia University Medical Center, New York-Presbyterian Hospital and the chairman of the ABSORB clinical trial program. "The available evidence supports an important role for this innovative device in the treatment of coronary artery disease."
The FDA routinely seeks input from advisory committees, especially for first-in-kind medical devices. The FDA's decision on Abbott's application for the Absorb dissolving stent is expected later this year.
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