Medtronic Submits First PMA Module for
Talent™ Thoracic Stent
Graft System
Minimally-Invasive Therapy Provides Option for Treating Aortic Aneurysms
MINNEAPOLIS, Nov. 17, 2005 -- Medtronic, Inc. (NYSE:MDT - News) today
announced that it has submitted its first pre-market approval (PMA) module to
the U.S. Food and Drug Administration for the Talent™ Thoracic stent graft
system. These stent grafts are used to treat thoracic aneurysms, which are dangerous
bulges in the aorta - the body's largest artery - that can rupture without warning.
Each year in America, thoracic aneurysms affect approximately 30,000 people. Patients typically have no symptoms 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 surgical repair difficult or 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. Stent graft therapy provides a minimally-invasive alternative, with reduced recovery times and potentially improved survival rates.
"This is an important step for our thoracic business in the United States," said Katie Szyman, Medtronic Vascular vice president and general manager of the Endovascular Innovations business. "In this country there are not a lot of choices for patients who have thoracic aneurysms. Medtronic is the leader in thoracic aneurysm therapy outside the United States and our goal is to provide improved options and outcomes for patients and physicians in the U.S. market."
Minimally-invasive therapy involves threading a stent graft through a small opening in the femoral artery of the leg. The stent is advanced under fluoroscopic guidance to the site of the thoracic aortic aneurysm or dissection, where it is then deployed. Once placed in the correct location, the stent graft expands to fit within the diameter of the aorta and provides a new path for the blood flow.
The Talent device has been commercially available in Europe and other areas outside the United States since 1999 and used in more than 18,000 procedures. Medtronic completed enrollment in its 338-patient VALOR clinical trial in June 2005. This pivotal study is evaluating the safety and efficacy of the Talent system, with patients followed for one year. Final VALOR results should be available in mid-2006, with approval for the Talent system anticipated in late 2006 or early 2007.
About Medtronic
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.
This press release contains forward-looking statements, including statements regarding anticipated regulatory approval and study completion dates, which are subject to risks and uncertainties, such as governmental regulation, general economic conditions and others described in Medtronic's Annual Report on Form 10-K for the year ended April 29, 2005. Actual results may differ materially from anticipated results. Medtronic does not undertake to update its forward-looking statements.
Source: Medtronic, Inc. |
