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Medtronic Receives FDA Approval for New AneuRx(R) AAAdvantage(TM) Abdominal Aortic Aneurysm Stent Graft System.


MINNEAPOLIS -- Medtronic, Inc. (NYSE NYSE

See: New York Stock Exchange
:MDT MDT
abbr.
Mountain Daylight Time


MDT (in the US and Canada) Mountain Daylight Time

MDT n abbr (US) (= mountain daylight time) →
) today announced that it has received U.S. Food and Drug Administration approval of the AneuRx(R) AAAdvantage(TM) abdominal aortic aneurysm abdominal aortic aneurysm A focal aortic dilation of ≥ 50% ↑ in diameter, accompanied by distension and weakened aortic wall Epidemiology Incidence is rising 12/105–1951; 36/105  (AAA AAA: see American Automobile Association.


(Triple A) A common single-cell battery used in a myriad of electronic devices of all variety. Like its double A (AA) cousin, it provides 1.5 volts of DC power. When used in series, the voltage is multiplied.
) stent graft with Xcelerant(R) 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(R) 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 ra·di·o·paque
adj.
Relatively impenetrable by x-rays or other forms of radiation.


radiopaque (rā´dēōpāk´),
adj
 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 interventional radiology Imaging A subspecialty of radiology that provides Diagnostic information–eg, CT-guided 'skinny' needle biopsies and dye injection for analysis of various lumina and tracts–eg, arteriography, cholangiography, antegrade  from University of North Carolina North Carolina, state in the SE United States. It is bordered by the Atlantic Ocean (E), South Carolina and Georgia (S), Tennessee (W), and Virginia (N). Facts and Figures


Area, 52,586 sq mi (136,198 sq km). Pop.
, 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 aneurysmal

pertaining to or arising from an aneurysm.


aneurysmal bone cyst
see bone cyst.
 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 femoral artery
n.
1. An artery with origin at the continuation of the external iliac artery, with branches to the pudendal, epigastric, circumflex iliac arteries, the deep artery of the thigh, and the descending genicular artery, and
 of the leg. The stent is advanced under fluoroscopic Fluoroscopic (fluoroscopy)
An x-ray procedure that produces immediate images and motion on a screen. The images look like those seen at airport baggage security stations.

Mentioned in: Hypotonic Duodenography
 guidance to the site of the abdominal aneurysm aneurysm (ăn`yrĭzəm), localized dilatation of a blood vessel, particularly an artery, or the heart. , 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(TM) AAA system outside the United States. In addition, Medtronic offers two stent grafts outside the U.S. that treat thoracic aneurysms, the Talent(TM) 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.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Quarterly Report on Form 10-Q for the quarter ended January 27, 2006. Actual results may differ materially from anticipated results.
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Publication:Business Wire
Date:Mar 27, 2006
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