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This information is intended for media
professionals and investors
News Release
Medtronic Submits First PMA
Module For Talent Thoracic Stent Graft System
Minimally-invasive therapy provides
optin for treating aortic aneurysms
MINNEAPOLIS – Nov. 17, 2005 – Medtronic,
Inc. (NYSE: MDT) today announced that it has submitted its
first pre-market approval (PMA) module to the U.S. Food and
Drug Administration for the Talent™ Thoracic stent graft
system. These stent grafts are used to treat thoracic
aneurysms, which are dangerous bulges in the aorta – the
body’s largest artery – that can rupture without warning.
Each year in America, thoracic aneurysms affect
approximately 30,000 people. Patients typically have no
symptoms and, when they are diagnosed, often undergo complex
open surgical repair. Many of these patients have other
serious conditions such as coronary artery disease, high blood
pressure or diabetes that make surgical repair difficult or
impossible. For those patients, conservative medical
management or “watchful waiting” is sometimes selected as a
treatment option. However, this can lead to increased
mortality and morbidity. Stent graft therapy provides a
minimally-invasive alternative, with reduced recovery times
and potentially improved survival rates.
“This is an important step for our thoracic business in the
United States,” said Katie Szyman, Medtronic Vascular vice
president and general manager of the Endovascular Innovations
business. “In this country there are not a lot of choices for
patients who have thoracic aneurysms. Medtronic is the leader
in thoracic aneurysm therapy outside the United States and our
goal is to provide improved options and outcomes for patients
and physicians in the U.S. market.”
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 thoracic aortic aneurysm or dissection, 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 the blood flow.
The Talent device has been commercially available in Europe
and other areas outside the United States since 1999 and used
in more than 18,000 procedures. Medtronic completed
enrollment in its 338-patient VALOR clinical trial in June
2005. This pivotal study is evaluating the safety and efficacy
of the Talent system, with patients followed for one year.
Final VALOR results should be available in mid-2006, with
approval for the Talent system anticipated in late 2006 or
early 2007.
About Medtronic
Medtronic, Inc. (http://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.
This press release contains forward-looking
statements, including statements regarding anticipated
regulatory approval and study completion dates, which are
subject to risks and uncertainties, such as governmental
regulation, general economic conditions and others described
in Medtronic’s Annual Report on Form 10-K for the year ended
April 29, 2005. Actual results may differ materially from
anticipated results. Medtronic does not undertake to update
its forward-looking statements.
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