Healthcare Industry News:  abdominal aortic aneurysm 

Devices Interventional FDA

 News Release - December 3, 2007

Medtronic Files PMA Application for FDA Approval of Talent(TM) Abdominal Stent Graft System

Submission Further Confirms Broad Patient Benefits of Endovascular abdominal aortic aneurysm Therapy Provided by Medtronic, the Market Leader in Stent Graft Technologies

MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ), today announced that it has filed the final module of its Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for the Talent™ Abdominal Stent Graft System. The Talent Abdominal Stent Graft is a minimally-invasive device that treats dangerous bulges in the aorta, the body’s largest artery that can rupture without warning.

The Talent Abdominal Stent Graft is designed to offer broad patient applicability and ease of use, and a history of established clinical performance with more than 40,000 implants worldwide. The results of the clinical trial demonstrated that the study met its primary safety endpoint of superiority in freedom from major adverse events at 30 days, and the aneurysm-related mortality rate at 12 months was 1.8 percent. Although patients receiving the Talent Abdominal Stent Graft were older and had a higher baseline rate of co-morbidities, they experienced lower rates of death, myocardial infarction, respiratory failure, paraplegia, and blood loss compared with subjects treated with open surgery at 12 months. There were no aneurysm ruptures and no conversions to open surgery in the Talent Abdominal Stent Graft group up to 12 months after device implantation.

“As part of the FDA’s modular review process, we have submitted the final module – a comprehensive clinical data set for the Talent Abdominal Stent Graft PMA application,” said Katie Szyman, vice president and general manager of the Endovascular Innovations business at Medtronic. “The Talent Abdominal System will expand treatment options for patients with abdominal aortic aneurysms and provide a strong complement to our market-leading AneuRx® AAAdvantage Stent Graft.”

Dr. Michael L. Marin, the Julius H. Jacobson II, M.D. professor of Vascular Surgery and chairman, Department of Surgery at The Mount Sinai Medical Center, cited the technical success of the stent graft system: “In my own experience, with more than 1,000 successful Talent Abdominal Stent Graft patient implantations, the performance of this stent graft has been very consistent, and its safety and efficacy have been well characterized through the results of the clinical trial.”

Medtronic has been an innovator and leader in the endovascular stent graft industry, as evidenced by more implants than any other company. Its long history includes more than 100,000 patients treated with aortic stent grafts dating back to 1995. In addition to the Talent Abdominal Stent Graft, the company also markets the AneuRx AAAdvantage Abdominal Stent Graft system in the United States and the Valiant Thoracic Stent Graft System outside the United States. Medtronic has also filed a PMA for its Talent Thoracic Stent Graft that is currently under evaluation by the FDA.

“With the AneuRx AAAdvantage and Talent Abdominal Stent Grafts, as well as the Talent and Valiant Thoracic Stent Grafts, Medtronic has the broadest portfolio of endovascular products in the global marketplace,” said Szyman. “Our leadership in this area is unmatched.”

The Talent Abdominal Stent Graft has been the stent graft of choice for physicians internationally for the past several years. The third generation of this device received CE Mark and has been commercially used in Europe (EEC) since 2002. The earliest version of the Talent Abdominal Stent Graft was first used clinically in Australia in 1995.

It is estimated that approximately 1.2 million people in the United States have an abdominal aortic aneurysm (AAA) condition. Only approximately 15 percent are ever diagnosed, even though nearly all AAAs can be detected through an inexpensive ultrasound screening test, and less than half of those are treated. Patients typically have no symptoms until the aneurysm ruptures. Once 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.

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 Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.


Source: Medtronic

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