Health Canada Approves Abbott's Absorb Bioresorbable Vascular Scaffold

July 14, 2016—Abbott Vascular announced that Health Canada has approved the company's Absorb bioresorbable heart stent for the treatment of patients with coronary artery disease. With the approval, Abbott plans to offer the Absorb bioresorbable stent to Canadian hospitals nationwide starting this summer.  The Absorb is designed to dissolve completely in approximately 3 years, once it has done its job of keeping a clogged artery open and promoting healing of the treated artery segment.

The device is sold commercially as the Absorb GT1 bioresorbable vascular scaffold (BVS) system. The device is available in more than 100 countries and was approved for use in the United States on July 5.

Philippe L. L’Allier, MD, commented in the company’s press release, “The Absorb stent is a significant advance in the way that coronary artery disease can be treated. Its novel technology means that once the stent has dissolved, the treated artery can pulse and flex as demands on the heart change with everyday activities. It also means physicians can more easily offer their patients other treatment options if necessary in a patient's future.” Dr. L’Allier is Director, Interventional Cardiology, at Montreal Heart Institute in Montreal, Quebec.

According to Abbott Vascular, the Absorb BVS demonstrated comparable short-term and midterm outcomes to Abbott’s Xience metallic drug-eluting stent in clinical studies conducted around the world. At 1 year, in a prespecified group of approximately 2,000 patients in the United States pivotal ABSORB III randomized clinical trial, patients who received the 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, target lesion failure)—as compared to patients who received the metallic Xience stent, reported the company.