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

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Heart Disease
Article Date: 07 May 2009 - 4:00 PDT

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Medtronic, Inc. (NYSE: MDT), have announced completion of enrollment in its investigational device exemption (IDE) study of the Endurant Stent Graft System, which is designed to enable the non-surgical repair of aortic aneurysms. Key data from this study, now expected in the second half of 2010, will be used to support the pre-market approval (PMA) submission for U.S. approval of Endurant.

"The clinical community is excited 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 now accelerated enrollment of the U.S. study."

"Initially approved for use internationally in July 2008, the Endurant system has a low profile and is designed to provide improved access and enhanced ease of use. Rapid enrollment in this study 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 president of the CardioVascular business at Medtronic.

"The system's design is intended to enable accuracy, control and simple deployment, while providing high conformability to the vessel wall. We look forward to bringing this next‐generation stent graft to the United States so even more abdominal aortic aneurysm patients can benefit from a minimally‐invasive alternative to open surgery."

Designed to evaluate the safety and effectiveness of the Endurant Stent Graft System 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 pioneer of endovascular aortic repair, Medtronic has been an innovator and leader in the stent graft industry since the 1990s. Its history includes more 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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