Interventional technology firm Medtronic has begun the first human study of its Endurant stent graft system for the treatment of abdominal aortic aneurysm (AAA).
Endurant is designed to improve conformability and trackability in tortuous aneurysmal anatomies, according to the Minneapolis-based firm. The research study will evaluate the safety and efficacy of Endurant at 10 sites in the Netherlands and Germany. Results will be used to support the device's CE Mark application, Medtronic said.
In related news, the company said that it has received conditional approval to begin its investigational device exemption (IDE) study of Endurant in the U.S. in early 2008. Dr. Michel Makaroun of the University of Pittsburgh School of Medicine in Pennsylvania will be the principal investigator of the U.S. research study, according to Medtronic.
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Medtronic launches CareLink in Europe, August 30, 2007
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