17.11.2005 22:06:00

Medtronic Submits First PMA Module for Talent(TM) Thoracic Stent Graft System; Minimally-Invasive Therapy Provides Option for Treating Aortic Aneurysms

Medtronic, Inc. (NYSE:MDT) today announced that it hassubmitted its first pre-market approval (PMA) module to the U.S. Foodand Drug Administration for the Talent(TM) Thoracic stent graftsystem. These stent grafts are used to treat thoracic aneurysms, whichare dangerous bulges in the aorta - the body's largest artery - thatcan rupture without warning.

Each year in America, thoracic aneurysms affect approximately30,000 people. Patients typically have no symptoms and, when they arediagnosed, often undergo complex open surgical repair. Many of thesepatients have other serious conditions such as coronary arterydisease, high blood pressure or diabetes that make surgical repairdifficult or impossible. For those patients, conservative medicalmanagement or "watchful waiting" is sometimes selected as a treatmentoption. However, this can lead to increased mortality and morbidity.Stent graft therapy provides a minimally-invasive alternative, withreduced recovery times and potentially improved survival rates.

"This is an important step for our thoracic business in the UnitedStates," said Katie Szyman, Medtronic Vascular vice president andgeneral manager of the Endovascular Innovations business. "In thiscountry there are not a lot of choices for patients who have thoracicaneurysms. Medtronic is the leader in thoracic aneurysm therapyoutside the United States and our goal is to provide improved optionsand outcomes for patients and physicians in the U.S. market."

Minimally-invasive therapy involves threading a stent graftthrough a small opening in the femoral artery of the leg. The stent isadvanced under fluoroscopic guidance to the site of the thoracicaortic aneurysm or dissection, where it is then deployed. Once placedin the correct location, the stent graft expands to fit within thediameter of the aorta and provides a new path for the blood flow.

The Talent device has been commercially available in Europe andother areas outside the United States since 1999 and used in more than18,000 procedures. Medtronic completed enrollment in its 338-patientVALOR clinical trial in June 2005. This pivotal study is evaluatingthe safety and efficacy of the Talent system, with patients followedfor one year. Final VALOR results should be available in mid-2006,with approval for the Talent system anticipated in late 2006 or early2007.

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 theworld.

This press release contains forward-looking statements, includingstatements regarding anticipated regulatory approval and studycompletion dates, which are subject to risks and uncertainties, suchas governmental regulation, general economic conditions and othersdescribed in Medtronic's Annual Report on Form 10-K for the year endedApril 29, 2005. Actual results may differ materially from anticipatedresults. Medtronic does not undertake to update its forward-lookingstatements.

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