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Medtronic begins first human study of stent graft system for AAA

Medtronic : 17 December, 2007  (New Product)
Medtronic has started the first human study of its Endurant Stent Graft System, an investigational treatment for abdominal aortic aneurysm (AAA).
The study is a major step toward expanding minimally invasive endovascular therapies.

The study supports Medtronic’s goal of providing physicians with a greater variety of solutions for treating patients with AAA a dangerous bulge or weakness in the body’s main artery that can rupture with fatal consequences if left untreated. The company’s AAA Stent Graft portfolio currently includes the AneuRx AAAdvantage platform in the USA and the Talent AAA platform outside the USA.

The Endurant Stent Graft System’s flexible features and lower delivery profile are designed to improve conformability and trackability in tortuous aneurysmal anatomies. “The Endurant Stent Graft System holds great promise as a minimally invasive treatment for AAA in patients with challenging anatomies,” said Prof Dr Hence Verhagen, chief of Vascular Surgery at Erasmus University Medical Center in Rotterdam, the Netherlands, and the Endurant research study’s principal investigator. “The device has several innovative design features that seek to address the concerns of seal, conformity to tortuous anatomy and deliverability for especially difficult AAA cases.”

The first implants of the Endurant Stent Graft System were performed by Prof Dr Verhagen and Prof Dr Frans Moll at the University Medical Center Utrecht, in Utrecht, the Netherlands, and by Prof Dr Giovanni Torsello and Dr. Thomas Umscheid at the St Franziskus-Hospital in Munster, Germany.

The Endurant research study will evaluate the safety and efficacy of the Endurant Stent Graft System at 10 sites in the Netherlands and Germany. The results will be used to support the device’s application for CE Mark, the European regulatory approval.

Medtronic has also received conditional approval to begin its Investigational Device Exemption (IDE) study of the Endurant Stent Graft System in the USA starting in early 2008.

The principal investigator of the US research study will be Dr Michel Makaroun, professor and chief of Vascular Surgery at the University of Pittsburgh School of Medicine.

“The Endurant Stent Graft System underscores our commitment to developing new and better ways to treat AAA with minimally invasive medical technology,” said Katie Szyman, vice president and general manager of the Endovascular Innovations business at Medtronic. “It represents an entirely new platform in our growing portfolio of endovascular therapy options.”

Medtronic has been an innovator and leader in the endovascular Stent Graft industry for more than a decade, as evidenced by more implants than any other company. The long history includes more than 100,000 patients treated with aortic Stent grafts dating back to 1995. Medtronic currently offers the broadest portfolio of endovascular Stent grafts in the industry. These include the AneuRx AAAdvantage Abdominal Stent Graft System in the USA, and the Talent Abdominal, Talent Thoracic and Valiant Thoracic Stent Graft Systems outside the USA.

In addition, Medtronic has filed applications with the FDA for approval of the Talent Abdominal and Thoracic Stent Graft Systems in the USA. The Endurant Stent Graft System is currently only available as part of the European research trial and is not approved commercially anywhere in the world.

Stent grafts represent an alternative treatment to open surgical repair for aortic aneurysms. They have been shown to be as effective as open surgery, with fewer complications and shorter recovery periods.

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