FDA Approves Abbott Vascular's Absorb Bioresorbable Vascular Scaffold

July 5, 2016—Abbott Vascular announced that the US Food and Drug Administration has approved the company's Absorb bioresorbable coronary stent. 

Sold commercially as the Absorb GT1 bioresorbable vascular scaffold (BVS) system, the device is now available in more than 100 countries, including the United States. Abbott plans to offer the Absorb GT1 BVS to hospitals in the United States, starting with interventional cardiology centers that participated in Absorb clinical trials.

Absorb is a fully dissolving stent approved for the treatment of coronary artery disease. The device is designed to completely dissolve in approximately 3 years after it has done its job of keeping a clogged artery open and promoting healing of the treated artery segment.

According to Abbott Vascular, in clinical studies conducted around the world, the Absorb bioresorbable stent demonstrated comparable short-term and midterm outcomes to Abbott's Xience drug-eluting metallic stent. In a prespecified group of approximately 2,000 patients in the United States in the pivotal ABSORB III randomized clinical trial, at 1 year, patients who received the dissolving Absorb stent experienced comparable rates of specific adverse events in the intended patient population (reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm)—including heart disease-related death, heart attacks attributed to the stented artery, and repeat procedures at the treated lesion (collectively termed as target lesion failure)—as compared to patients who received the metallic Xience stent.

In the company’s press release, Gregg W. Stone, MD, commented, “The Absorb bioresorbable scaffold represents a major advance in the treatment of coronary artery disease. This novel technology appeals to both physicians and patients alike because after treating the underlying blockage it is completely absorbed, leaving nothing behind. No metal means the treated artery can pulse and flex naturally as demands on the heart change with everyday activities. No metal may also reduce the potential of future blockages that occur with permanent metallic stents, and allows easier access to other treatment options should they prove necessary in the patient's future." Dr. Stone is Director, Cardiovascular Research and Education, at the Center for Interventional Vascular Therapy, Columbia University Medical Center, New York-Presbyterian Hospital in New York, New York. Dr. Stone served as chairman of the ABSORB clinical trial program.