Medtronic initiates global abdominal aortic aneurysm study
24 April 2009
Medtronic, Inc. (NYSE: MDT), has announced the start of ENGAGE¹, 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.”
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.
“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 centres 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 the CE mark in July 2008 for marketing in the EU 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.
Bookmark this page