FDA APPROVES ABBOTT’S ABSORB™ BIORESORBABLE STENT, THE ONLY FULLY DISSOLVING HEART STENT
Available in Southeast Region Only at North Mississippi Medical Center
TUPELO, Miss.—Abbott announced this week that the U.S. Food and Drug Administration has approved the company’s Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people with coronary artery disease in the United States.
Interventional cardiologist Barry Bertolet, M.D., implanted the nation’s first Absorb stent at North Mississippi Medical Center on Dec. 28, 2012, in a clinical trial for the device. Phyllis Camp of Tupelo was the first patient and continues to do well more than three years after her device was implanted. In all, NMMC cardiologists implanted approximately 50 Absorb stents during the clinical trial.
For the next several months, Abbott will offer the device only to hospitals that participated in Absorb clinical trials. NMMC is the only site in Mississippi and the southeast region where the device will be available, and implanted the region’s first commercial Absorb stent on July 14.
Absorb works by restoring blood flow to the heart similar to a metal stent, but then dissolves slowly into water and carbon dioxide. The result is a treated vessel that may resume more natural function and movement because it is free of a permanent metal stent, thereby also avoiding the complications of a permanent implant.
Absorb is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures. The device is referred to as a scaffold because it is a temporary structure, unlike a stent, which is a permanent implant. The scaffold supports the vessel until the artery can stay open on its own, and then dissolves naturally. The device disappears completely in approximately three years. By contrast, metal stents are permanent implants that restrict vessel motion for the life of the person treated.
The potential long-term benefits of a scaffold that dissolves are significant. The vessel may expand and contract as needed to increase the flow of blood to the heart in response to normal activities such as exercising; treatment and diagnostic options are broadened; the need for long-term treatment with anticlotting medications may be reduced; and future interventions would be unobstructed by a permanent implant.
“The Absorb resorbable scaffold offers a huge advance in the technology that can be offered to patients with coronary heart disease. Physicians and patients alike have realized the benefit and convenience of absorbable sutures,” Dr. Bertolet said. “The sutures are there when you need the support for healing, and then they are gone. This same benefit is now available through the Absorb scaffold for heart disease patients.”
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 U.S. patients in the pivotal ABSORB III randomized 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.
For more information about services available through the NMMC Heart Institute, call 1-800- THE DESK (1-800-843-3375). For more information on Absorb, visit www.dissolvingstent.com.