Endologix Completes Patient Enrollment in the Ovation LIFE Study

May 16, 2016—Endologix, Inc. announced the completion of patient enrollment in the LIFE study, a multicenter postmarket registry designed to evaluate the company’s Ovation abdominal stent graft platform when used in the treatment of patients with abdominal aortic aneurysms (AAAs) using a fast-track protocol for endovascular aneurysm repair (EVAR). 

According to Endologix, the LIFE (Least Invasive Fast-Track EVAR) study is the first of its kind using a fast-track EVAR protocol, which includes bilateral percutaneous access enabled by the Ovation platform’s ultra-low-profile (14-F) design, avoidance of general anesthesia and intensive care unit (ICU) admission postprocedure, and next-day discharge. 

The study enrolled 250 patients at 34 sites in the United States. The primary endpoint of the study is the 30-day rate of major adverse events. The results from the LIFE study are expected to be presented in the fall of 2016. 

The LIFE study is led by National Principal Investigators Zvonimir Krajcer, MD, and Venkatesh G. Ramaiah, MD. Dr. Krajcer is Co-Director, Peripheral Vascular Disease Service at Texas Heart Institute in Houston, Texas. Dr. Ramaiah is Director of Research at the Arizona Heart Institute and Medical Director of the Arizona Heart Hospital in Phoenix, Arizona.

In the company’s press release, Dr. Krajcer commented, “The LIFE study provides us the ability to risk stratify AAA 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.”

Dr. Ramaiah added, “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 anesthesia and subsequent ICU stay. The fast-track EVAR option utilizes the least invasive approach via bilateral percutaneous access and is enabled by the Ovation Platform's ultra-low-profile (14-F) design.” He continued, “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.”