Medtronic Announces Key Milestones in Endovascular Repair at Society for Vascular Surgery Meeting
MINNEAPOLIS, 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.
"The advent of stent graft therapy has given patients an effective, minimally-invasive alternative to open surgery, with reduced recovery times and potentially improved survival rates," said Katie Szyman, vice president and general manager of Medtronic's Endovascular business in Santa Rosa, Calif. "Medtronic's decade of experience in treating aortic aneurysms is well-recognized in the industry, and we are committed to working closely with the SVS to bring life-saving and cost-effective products to market to help fight these dangerous medical conditions."
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.
Contact:
Medtronic, Inc., Minneapolis
Public Relations:
Scott Papillon, 707-591-7367
or
Investor Relations:
Rachael Scherer, 763-505-2694
Source: Medtronic, Inc. |