Medtronic Inc. (NYSE:MDT) made the first enrollment in a U.S. clinical trial testing the use of a stent graft in patients with a potentially life-threatening cardiovascular condition.
The 50-patient trial will test the company’s Valiant Thoracic Stent Graft on patients with Type B aortic dissection, a condition in which there is bleeding into and along the wall of the aorta, the major artery leaving the heart, according to a statement from Fridley, Minnesota-based Medtronic.
The trial’s aim is to determine if the stent graft is a safe and effective alternative to invasive surgery for patients suffering from the condition. A stent graft is a metal tube that’s delivered through a catheter and conforms to the wall of the aorta, the body’s main artery, creating a new path for blood flow, according to the statement.
Doctors often use stent grafts to treat aneursyms, the weakening and enlargement of a portion of the artery.
The Valiant Thoracic was approved for sales in Europe in 2005 and is in use in 90 countries. Positive results in the U.S.clinical trial could bring the device closer to federal regulatory approval.