Endologix has completed patient enrolment in the LIFE (Least invasive fast-track EVAR) study, a multicentre post-market registry designed to evaluate the Ovation abdominal stent graft platform when used in the treatment of patients with abdominal aortic aneurysms using a fast-track EVAR protocol. The LIFE study is the first of its kind using a fast-track EVAR protocol, which includes bilateral percutaneous access enabled by the Ovation platform ultra-low profile (14F) design, avoidance of general anaesthesia and intensive care unit admission post-procedure, and next-day discharge.
The LIFE study enrolled 250 patients at 34 sites in the USA. The primary endpoint of the study is the 30-day major adverse event rate. The results from the LIFE study are anticipated to be presented at a medical meeting in autumn 2016. The LIFE study is led by national principal investigators Zvonimir Krajcer, co-director, Peripheral Vascular Disease Service at Texas Heart Institute in Houston, USA, and Venkatesh G Ramaiah, director of research at the Arizona Heart Institute and Medical Director of the Arizona Heart Hospital in Phoenix, USA.
Krajcer commented, “The LIFE study provides us the ability to risk stratify abdominal aortic aneurysm patients and offer them a fast-track option which is compelling for patients, physicians and the hospital. The preliminary data presented in November 2015 demonstrated a meaningful reduction in procedure time and length of stay, which should translate into measurable cost-savings and higher patient satisfaction. We look forward to completing the patient follow-up and data-analysis and presenting the results at an upcoming medical meeting.”
Ramaiah said, “Traditionally, EVAR procedures have required surgical exposure of the common femoral artery to gain endovascular access to the diseased aorta. While this is significantly less invasive than an open surgical approach, it often requires more than one night in the hospital due to the use of general anaesthesia and subsequent intensive care unit stay. The fast-track EVAR option utilises the least invasive approach via bilateral percutaneous access and is enabled by the Ovation platform’s ultra-low profile (14F) design. The preliminary data from the LIFE study are encouraging and suggest that the Fast-Track with the Ovation platform is feasible, safe, and may improve efficiency of healthcare resource allocation in patients undergoing EVAR.”
John McDermott, chairman and chief executive officer of Endologix, said, “The completion of enrolment in the LIFE study is another important milestone in our efforts to continue building the clinical and economic evidence in support of our portfolio of abdominal aortic aneurysm products.”