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Medtronic Receives FDA Approval for New AneuRx® AAAdvantage™ Abdominal Aortic Aneurysm Stent Graft System |
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28 Mar 2006 |
MINNEAPOLIS, IN, USA | Mar 27, 2006 | Medtronic, Inc. (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration approval of the AneuRx® AAAdvantage™ abdominal aortic aneurysm (AAA) stent graft with Xcelerant® delivery system. AneuRx AAAdvantage is a next-generation, minimally-invasive device that treats dangerous bulges in the aorta, the body’s largest artery, that can rupture without warning.
It is estimated that approximately 1.2 million people in the United States have an AAA condition. Only about 15 percent are ever diagnosed and less than half of those are ever treated. Patients typically have no symptoms and, when they are diagnosed, they often undergo complex open surgical repair. Stent graft therapy provides a minimally-invasive alternative, with reduced recovery times and potentially improved survival rates. The AneuRx AAAdvantage system offers physicians a low profile for ease of use and a wider range of lengths, diameters and other enhancements that allow broader patient applicability than prior generation Medtronic devices.
“We believe that experience is the foundation of innovation. After a decade of endovascular repair procedures with the AneuRx® device, we have the most experience in this therapy,” said Katie Szyman, Medtronic Vascular vice president and general manager of the Endovascular Innovations business. “Because of our experience, we’ve been able to design a stent graft system that gives physicians more control during implantation and additional options to help provide this life-saving treatment to more patients.”
Enhancements to the new AAAdvantage system include:
* potentially broader proximal and distal sealing areas due to longer aortic bodies, longer and larger straight iliac limbs, and flared iliac limbs and extensions
* improved radiopaque markers
* contoured stents
These enhancements will provide greater patient applicability, help reduce the complexity of the procedure and upgrade the durability of the stent graft. Additional enhancements are planned for the near future.
Dr. Mark Farber, Associate Professor of Vascular Surgery and Interventional Radiology from University of North Carolina, noted the system’s ease of use. “The AneuRx AAAdvantage system demonstrates Medtronic’s continued commitment to the endovascular community and allows physicians to easily and precisely treat patients with a broad range of aneurysmal disease,” he said.
The AneuRx AAAdvantage system builds on the strong history developed with the original AneuRx AAA system, which has been available in the U.S. since 1999. More than 55,000 patients have received AneuRx stent grafts.
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 abdominal aneurysm, 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 blood flow.
Medtronic currently markets four stent graft systems, including the AneuRx AAA stent graft system in the United States and the Talent™ AAA system outside the United States. In addition, Medtronic offers two stent grafts outside the U.S. that treat thoracic aneurysms, the Talent™ Thoracic and the Valiant Thoracic systems. The Talent thoracic system also is in clinical trials in the United States.
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.
SOURCE: Medtronic, Inc. |
