The FDA approved Abbott’s ($ABT) Absorb bioresorbable stent for the treatment of coronary artery disease, the company announced Tuesday. It is the first approved fully dissolving heart stent.
In coronary artery disease, cholesterol deposits collect along the inner walls of the arteries, which lowers the blood supply to the heart. It is traditionally treated by the insertion of a permanent metallic stent to help prop the artery open, but metal stents come with a number of disadvantages. For example, their permanence means that artery motion is limited for the rest of a patient’s life, and that there is a risk of scar tissue forming within the stent itself, causing the artery to renarrow.
Like metal stents, Absorb treats coronary artery disease by supporting the inner wall of a narrowed artery. It elutes the drug everolimus, which reduces inflammation and the formation of scar tissue and also promotes healing. It is made from a polymer similar to materials used in other absorbable devices, such as sutures.
"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," said Dr. Gregg Stone, director of cardiovascular research and education at Columbia University Medical Centers' Center for Interventional Vascular Therapy and chairman of the ABSORB clinical trial program, in an Abbott statement.
According to Abbott, the stent reabsorbs completely within three years of implantation, once it’s done helping the artery heal. The stent breaks down over time into water and carbon dioxide, leaving behind only four “very small” platinum markers embedded in the artery walls to indicate where the implant was placed.
According to the CDC, coronary artery disease is the most common type of heart disease, killing more than 370,000 people each year. The Absorb stent is an alternative treatment for patients who are eligible for angioplasty--treatment with a permanent metal stent--but who would prefer an absorbable device, Dr. Bram Zuckerman, director of the division of cardiovascular devices at the FDA’s CDRH, in the FDA's statement.
The approval comes after a unanimous vote to recommend the device for approval from the FDA’s Circulatory System Devices Panel in March. Abbott pitted Absorb against its Xience metallic drug-eluting stent, finding that they had comparable short- to mid-term outcomes. Abbott plans to make Absorb available to U.S. hospitals, beginning with the interventional cardiology centers that participated in the clinical trials for the device.
- read Abbott's statement
- read the FDA statement
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