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Absorb Bioresorbable Stent Wins FDA Nod
The FDA has approved the Absorb bioresorbable heart stent (Abbott) for the treatment of patients with coronary artery disease (CAD). Absorb is the only fully dissolving stent approved for CAD, which affects 15 million people in the United States and remains a leading cause of death worldwide.
While heart stents are traditionally made of metal, the Absorb stent is made of a naturally dissolving material, similar to dissolving sutures. Absorb stents disappear completely in approximately three years. In contrast, metal stents are permanent implants that restrict vessel motion for the life of the person treated.
Abbott plans to offer the Absorb devices to hospitals in the U.S., starting with interventional cardiology centers that participated in clinical trials of the stent.
In studies conducted around the world, Absorb bioresorbable stents demonstrated short-term and mid-term outcomes that were comparable with those of the leading metallic stent—Abbott’s Xience drug-eluting stent. In the pivotal 52-week, randomized ABSORB III clinical trial, approximately 2,000 U.S. patients who received the dissolving Absorb stent experienced rates of adverse events in the intended patient population (reference vessel diameter of 2.5 mm to 3.75 mm)—including heart disease-related death, heart attacks attributed to the stented artery, and repeat procedures at the treated lesion (collectively termed target lesion failure)—that were comparable with those in patients who received the metallic Xience stent.
The Absorb stent, sold commercially as the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) system, is now available in more than 100 countries, including the U.S., and has been used to treat more than 150,000 people with CAD worldwide.
Source: PR Newswire; July 5, 2016.