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Medtronic Completes Early Enrolment In U.S. Study Of Endurant Abdominal Aortic Stent Graft

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Medtronic, Inc. (NYSE: MDT), have announced completion of enrollment in its investigational slogan exemption (IDE) study of the Endurant Stent Scion System, which is designed to enable the non-surgical repair of aortic aneurysms. Key info from this study, now expected in the moment half of 2010, testament be used to benefit the pre-market approval (PMA) submission for U.S. approval of Endurant.
"The clinical community is agitated by what this device offers to patients," said the study's principal investigator, Dr. Michel Makaroun of the University of Pittsburgh School of Medicine. "The device combines unique improvements with the best features from existing technology. Enthusiastic clinician interest is evident from Endurant's rapid adoption in Europe, and directly quick enrollment of the U.S. study."
"Initially approved for use internationally in July 2008, the Endurant process has a low profile and is designed to dispense improved access and enhanced support of use. Rapid enrollment in this interpret increases the likelihood of earlier U.S. approval and is continued evidence of Medtronic's leadership, momentum and commitment to innovation in this field," said Tony Semedo, general manager of the Endovascular Innovations division and vice head of the state of the CardioVascular business at Medtronic.
"The system's mannequin is intended to enable accuracy, containment and no problem deployment, while providing colossal conformability to the vessel wall. We look forward to bringing this next‚ procreation stent graft to the United States so even more abdominal aortic aneurysm patients can assistance from a minimally‚ invasive alternative to govern surgery."
Designed to evaluate the safety and effectiveness of the Endurant Stent Graft Operation for the endovascular aortic repair (EVAR) of abdominal aneurysms, the U.S. Endurant IDE study was enrolled two months ahead of schedule, having started in 2008 and involving 30 sites.
A explorer of endovascular aortic repair, Medtronic has been an innovator and bigwig in the stent graft industry since the 1990s. Its history includes amassed than 150,000 patients treated with stent grafts. Medtronic offers the broadest portfolio of aortic stent grafts. Among these are the Talent Abdominal and Thoracic Stent Grafts in the United States, as well as the Endurant® Abdominal and the Valiant® Thoracic Stent Grafts outside the United States.
Source
Medtronic, Inc.
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Keywords:

stent, stent graft, stent grafts, aortic stent, endurant stent, thoracic stent, stent scion, procreation stent, treated stent, bigwig stent
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