Medtronic commences abdominal aortic aneurysm stent graft study

Medtronic, Inc. has announced the start of ENGAGE, the largest ever study of its kind, which will evaluate the performance of the Endurant stent graft, an implantable medical device 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," according to Dr. Robert Fitridge of 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."

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.

"Around half of aortic repair procedures are currently performed using endovascular stent grafts. The ENGAGE study is designed to provide clinicians with enhanced confidence in the performance and ease of use of the Endurant stent graft, so even more patients benefit from a life-saving procedure without the need for open surgery," said Tony Semedo, vice president of CardioVascular and general manager of the Endovascular Innovations division at Medtronic.

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 which 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.

The Endurant stent graft system expands Medtronic's portfolio of aortic repair technologies, which offer physicians a broad array of devices to choose from in treating patients with aortic aneurysms. It received Conformité Européene mark in July 2008 and is now commercially available in more than 80 countries. Use of the Endurant stent graft system in the United States is limited to an investigational clinical trial.

A pioneer of endovascular aneurysm 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. The AneuRx AAAdvantage and Talent Abdominal Stent Grafts with the Xcelerant Hydro Delivery System and the Talent Thoracic Stent Graft with the Xcelerant Delivery System are commercially available in the United States. The Valiant Thoracic Stent Graft and the Endurant Stent Graft Systems are commercially available only outside the United States and are currently under clinical investigation in the United States. The Reliant Stent Graft Balloon Catheter is commercially available worldwide.