Endologix has announced the enrolment of the first patient in the EVAS FORWARD-IDE clinical trial, designed to assess the safety and effectiveness of its Nellix endovascular aneurysm sealing (EVAS) system for the endovascular repair of infrarenal abdominal aortic aneurysms.
The first procedure was performed at Heidelberg University Hospital in Germany.
The EVAS FORWARD-IDE clinical trial will enrol 180 patients at up to 30 centres in the US, Canada and Europe. Of the 30 centres, approximately 25 will be in the US.
It is one of a number of clinical studies that make up the broader EVAS FORWARD clinical programme aimed at establishing clinical and economic evidence for EVAS using Nellix.
Nellix is an investigational endovascular aneurysm sealing system designed for the treatment of infrarenal abdominal aortic aneurysm (AAA).
EVAS is a next-generation AAA therapy intended to treat more anatomies than currently approved endovascular stent graft devices, and is the only technology whose operating principle is centred on sealing the aneurysm sac.
Nellix was designed to address unmet clinical needs, and potentially reduce the need for secondary interventions following endovascular AAA repair.
Endologix chairman and CEO John Mcdermott noted the beginning of enrolment in the EVAS FORWARD-IDE clinical trial is a positive milestone for the company as it continues to expand its innovative portfolio of endovascular aortic devices.
"The experience in the first IDE procedure matched our expectations based on our international clinical trial results and early commercial results in Europe," McDermott said.
"Based on the anticipated enrolment timeline and one-year follow-up period, the Nellix EVAS System could potentially be available to physicians and patients in the US by the end of 2016."
The Nellix EVAS system has obtained CE Mark approval in the first quarter of 2013. Limited commercial release of the product in Europe is currently underway.
Image: Abdominal aortic aneurysm. Photo: courtesy of Intermedichbo.