Healthcare Industry News: abdominal aortic aneurysm
News Release - March 5, 2007
Medtronic Submits Pre-Market Approval Application to the FDA for the Talent(TM) Thoracic Stent Graft SystemMinimally Invasive Therapy Provides Treatment Option to Open Surgery for Patients with Aneurysms in Upper Portion of Aorta
MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) said today that it has submitted the final module of its pre-market approval (PMA) application to the U.S. Food and Drug Administration for approval to commercially market and sell the Talent(TM) Thoracic stent graft system. The Talent Thoracic stent graft provides a minimally-invasive treatment alternative to open surgery for patients who develop life-threatening aneurysms in the upper portion of the aorta, the body's largest artery.
Aneurysms are dangerous bulges or weaknesses in the aorta which, left untreated, can rupture without warning. Each year in America, thoracic aneurysms affect approximately 30,000 people, causing thousands of deaths.
"This is a significant milestone for our thoracic business in the United States," said Katie Szyman, vice president and general manager of the Endovascular Innovations group within the Vascular business unit at Medtronic. "Medtronic has been a recognized leader in treating thoracic aneurysms outside the United States and we are excited at the prospect of bringing this technology and our many years of clinical experience to the U.S. market. The Talent Thoracic device is a product that can truly benefit patients suffering from this life-threatening disease."
Patients typically have no symptoms from aneurysms and, when they are diagnosed, often undergo complex open surgical repair. Many of these patients have other serious conditions such as coronary artery disease, high blood pressure or diabetes that make surgery difficult or even impossible. For those patients, conservative medical management or "watchful waiting" is sometimes selected as a treatment option. However, this can lead to increased mortality and morbidity.
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.
"With AneuRx, Talent and Valiant, Medtronic has the broadest portfolio of endovascular products in the marketplace," said Szyman. "Our leadership in this area is unmatched."
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
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