Healthcare Industry News: aortic dissection
News Release - June 2, 2006
Medtronic Announces Key Milestones in Endovascular Repair at Society for Vascular Surgery MeetingMINNEAPOLIS--(HSMN NewsFeed)--June 2, 2006--Medtronic, Inc. (NYSE:MDT ), the worldwide leader in endovascular therapy, today announced several key milestones in its minimally-invasive endovascular repair program, including more than 100,000 endograft implants since the company introduced its first aortic stent graft systems in 1995. The company made the announcement in conjunction with the 60th annual Society for Vascular Surgery meeting in Philadelphia.
Among the milestones:
- Medtronic now has more than 10 years of clinical experience with its endograft implants, by far the most clinical experience in the vascular industry. In the last decade, more than 100,000 Medtronic stent grafts have been implanted worldwide for abdominal aortic aneurysms (AAA) or thoracic lesions. Stent grafts are designed to protect against the sudden rupture of the aorta, the body's largest artery. Approximately two million people in the United States have either abdominal aortic aneurysms or thoracic lesions, and only about 15 percent are ever diagnosed.
- Medtronic has completed one-year follow-up on approximately 350 patients from the VALOR (Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms) clinical trial. VALOR is a pivotal study evaluating the Talent Thoracic system at 40 centers in the United States. Data from the VALOR trial will be presented at a future endovascular medical meeting and these results will be used for submission to the U.S. Food and Drug Administration (FDA) for approval of the Talent Thoracic system, which has been available outside the U.S. since 1997.
- At a special recognition breakfast on Saturday, June 3, Medtronic and the SVS will celebrate the recent passage of legislation that will make free, one-time AAA screening part of the Welcome to Medicare physical for qualifying patients. This important initiative, which takes effect Jan. 1, 2007 as an amendment to the Social Security Act, was led by Dr. Robert Zwolak, professor of surgery at Dartmouth Medical School, and supported by Medtronic, the SVS and the National Aneurysm Alliance (NAA), a group of medical professional organizations, patient advocates and medical technology manufacturers. Key provisions of the "Screening Abdominal Aortic Aneurysms Very Efficiently (SAAAVE) Act" were part of the final budget reconciliation package signed by President George W. Bush in February. The covered patient population includes men age 65 and older who have been smokers, and both men and women with a family history of AAA. During the past two years, Medtronic has been one of the leading industry advocates of AAA screenings, conducting free screenings for more than 25,000 people at hundreds of locations around the country.
- Medtronic also has announced plans to start the VIRTUE post-market patient registry to evaluate the treatment of acute, sub-acute and chronic descending thoracic aortic dissections (Type B). VIRTUE will enroll 100 patients at approximately 15-20 clinical centers in Europe, with a primary endpoint of disease, procedure or device related mortality at 12 months post-procedure. The principal investigator is Prof. Matt Thompson, Saint George's Hospital, University of London, U.K. The objective of the registry is to also collect additional clinical performance and health economics data on the treatment of Type B aortic dissections using the Valiant Thoracic Stent Graft with the Xcelerant Delivery System.
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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