Medtronic, Inc. announced today that the FDA has approved the company's Valiant® Captivia® stent graft system for the endovascular repair of isolated lesions (excluding dissections) of the descending segment of the thoracic aorta. This expanded indication includes the treatment of transections, commonly known as blunt traumatic aortic injuries.
The second leading cause of traumatic death after head injuries, transection of the thoracic aorta represents a dire medical emergency in which the upper area of the body's main artery tears due to extreme force to the chest, usually the result of motor vehicle accidents, elevated falls or other high-impact deceleration episodes.
The Valiant stent graft, a tubular medical device consisting of a specially woven fabric sewn onto a flexible wire-mesh frame, can now be used in U.S. clinical practice to stabilize bleeding from descending thoracic aortic transections as an alternative to invasive surgery.
Previously approved by the FDA for the endovascular repair of aneurysms and penetrating ulcers of the descending thoracic aorta, the Valiant Captivia stent graft system has been widely available in the United States since May 2012.
The device is implanted in a minimally invasive procedure that uses a catheter inserted into the femoral artery, located in the groin. This technique requires only a small incision to access the aorta as opposed to larger incisions required for open surgery.
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The second leading cause of traumatic death after head injuries, transection of the thoracic aorta represents a dire medical emergency in which the upper area of the body's main artery tears due to extreme force to the chest, usually the result of motor vehicle accidents, elevated falls or other high-impact deceleration episodes.
The Valiant stent graft, a tubular medical device consisting of a specially woven fabric sewn onto a flexible wire-mesh frame, can now be used in U.S. clinical practice to stabilize bleeding from descending thoracic aortic transections as an alternative to invasive surgery.
Previously approved by the FDA for the endovascular repair of aneurysms and penetrating ulcers of the descending thoracic aorta, the Valiant Captivia stent graft system has been widely available in the United States since May 2012.
The device is implanted in a minimally invasive procedure that uses a catheter inserted into the femoral artery, located in the groin. This technique requires only a small incision to access the aorta as opposed to larger incisions required for open surgery.
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