Evaluation of Medtronic’s Endurant Stent Graft Begins
April 15, 2009 - Medtronic Inc. today announced the initiation of the global abdominal aortic aneurysm study known as ENGAGE, which will evaluate the performance of the Endurant stent graft, designed to provide an advanced minimally invasive alternative to open surgical repair of abdominal aortic aneurysms.
“ENGAGE seeks to involve more patients, at more sites and in more countries than any previous study of its kind,” said Robert Fitridge, M.D., The Queen Elizabeth Hospital in Adelaide, Australia, one of the study’s seven executive committee members. “The data this multicenter international study collects on the Endurant stent graft will help physicians worldwide determine how best to treat abdominal aortic aneurysms in the real-world setting of standard clinical practice.”
ENGAGE is expected to enroll 1,200 patients with abdominal aortic aneurysms at up to 80 medical centers across six continents. Patients who meet the single-arm study’s inclusion criteria will be treated with the Endurant system and followed for five years. The study’s primary endpoint is treatment success at 12 months. Treatment success is a composite endpoint that requires the satisfaction of several criteria. These criteria include successful technical delivery and deployment of the stent graft as well as freedom from: aneurysm swelling; endoleaks; aneurysm rupture; conversion to surgery; graft migration; and graft occlusion.
Dr. Fitridge led the team that enrolled the first patient in this global post-market study on March 24. The other six ENGAGE executive committee members include: Drs. Dittmar Böckler of the University of Heidelberg in Germany; Paul Hayes of Addenbrookes Hospital in Cambridge, England; Furuzan Numan of Memorial Hospital in Istanbul, Turkey; Juan Carlos Parodi of FLENI in Buenos Aires, Argentina; Vicente Riambau of Hospital Clínico de Barcelona in Spain; and Yehuda Wolf of Sourasky Medical Center in Tel-Aviv, Israel.
Use of the Endurant stent graft system in the U.S. is limited to an investigational clinical trial.
For more information: www.medtronic.com
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