The device is made of naturally dissolving material
The US Food and Drug Administration (US FDA) has approved Abott’s Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people with coronary artery disease in the US.
Abbott’s Absorb stent is made of a naturally dissolving material, similar to dissolving sutures. Absorb disappears completely in approximately three years, after it has done its job of keeping a clogged artery open and promoting healing of the treated artery segment. By contrast, metal stents are permanent implants that restrict vessel motion for the life of the person treated.
Abbott plans to offer the Absorb device to hospitals in the US, starting with interventional cardiology centres that participated in Absorb clinical trials.
In clinical studies conducted around the world, the Absorb bioresorbable stent demonstrated comparable short-term and mid-term outcomes to the leading metallic stent–Abbott’s Xience drug eluting stent. At one year in a pre-specified group of approximately 2,000 US patients in the pivotal ABSORB III randomised clinical trial, 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 target lesion failure)–as compared to patients who received the metallic Xience stent.
Abbott’s Absorb stent, sold commercially as the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) system, is now available in more than 100 countries, including the US, and has been used to treat more than 150,0002 people with coronary artery disease worldwide.
EH News Bureau
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