FDA approves Medtronic stent to treat aortic aneurysms.
In a move that could significantly expand the market for aortic stent treatment, federal regulators have approved a stent system made by Medtronic Inc. that repairs deadly bulges in the body's largest artery.
The FDA approved the company's Talent stent system to treat aneurysms of the aorta, a vessel that delivers blood throughout the body. Aortic aneurysms lead to death in more than 15,000 people each year, according to statistics from the US Centers for Disease Control and Prevention. The affliction is the 10th leading cause of death among men older than 55.
Medtronic's Talent stent system consists of a mesh-metal tube coated in polyester that is designed to provide extra space for blood flow, reducing pressure on the aneurysm. Medtronic calls the device the "next generation version" of the Aneurx, its current aortic stent.
The FDA approved Medtronic's new stent system based on studies showing patients treated with the device had fewer complications than those who underwent traditional surgery to open the chest cavity. The Talent stent is inserted through a small incision in a patient's leg.
"The Talent Abdominal Stent Graft has provided excellent patient outcomes in clinical practice and in clinical study," said Dr. Michael L. Marin, professor of vascular surgery and chairman of the Department of Surgery at Mount Sinai Medical Center in New York, NY. "In my own experience, with more than 750 implants using the Talent system, the performance of this stent has been very consistent, and its safety and efficacy have been well characterized through the results of our own clinical trial."