Medtronic, Inc. has just submitted the final pre-market approval documents to the FDA for its Talent™ Thoracic Stent Graft System. At the present time there is no evidence to expect that the FDA would create any hurdles for the company to commercially market and sell its endovascular system for descending thoracic aneurysms.
From the press release:
Minimally invasive therapies, such as endovascular stent grafting, provide potential benefits including reduced surgical morbidity, reduced hospital stay, and an improved quality of life. The procedure involves threading the stent graft through a small opening in the femoral artery of the leg. The stent graft is advanced under fluoroscopic guidance to the site of the thoracic aortic aneurysm, where it is then positioned and deployed from the delivery system. Once deployed, the stent graft expands to fit snugly within the diameter of the aorta, providing a new path for the blood flow.
Medtronic has been at the forefront of the endovascular stent graft industry, with more clinical research and product implants than any other company. Its long history includes more than 100,000 patients treated with aortic stent grafts dating back to 1996. In addition to the Talent Thoracic stent graft, the company also markets the Valiant Thoracic Stent Graft System outside the United States. Medtronic also offers two stent grafts for abdominal aortic aneurysms (AAA): the Talent Abdominal Stent Graft system outside the U.S. and the popular AneuRx® AAAdvantage Abdominal Stent Graft system in the U.S. Medtronic plans to submit its PMA for Talent Abdominal later this year.