TriVascular Begins LIFE Postmarket Registry for Ovation Prime in Fast-Track Setting

October 27, 2014—TriVascular Technologies, Inc. announced the commencement of enrollment in the LIFE Study, a multicenter postmarket registry designed to evaluate the Ovation Prime abdominal stent graft system in the treatment of patients with abdominal aortic aneurysms (AAA) using a fast-track protocol for endovascular aneurysm repair (EVAR).

According to the company, the primary objectives of the LIFE (Least Invasive Fast-Track EVAR) study are to demonstrate the clinical benefits and cost benefits associated with using the Ovation Prime system in this setting. Key elements of the protocol include: patient eligibility for the Ovation Prime system, bilateral percutaneous access, avoidance of general anesthesia, no intensive care unit (ICU) admission, and next day discharge. The study will enroll 250 patients at up to 40 sites in the United States. The primary endpoint is the 30-day rate of major adverse events.

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. Wayne K. Nelson, MD, treated the first patient in the LIFE study at Bend Memorial Clinic and St. Charles Hospital in Bend, Oregon.

In the TriVascular's press release, Dr. Nelson commented, “We are excited to enroll the first patient in the LIFE study. The Ovation Prime system is uniquely suited to a fast-track protocol due to its low profile and ease of use. Our patient recovered smoothly and went home the next day. The ability to risk stratify AAA patients and offer them a fast-track option is compelling for patients, physicians and the hospital. We are looking forward to continued enrollment in the LIFE study.”

Also in the company's announcement, Dr. Ramaiah stated, “Despite technological and clinical advancement, EVAR typically involves surgical exposure of the common femoral artery, general anesthesia, a 1-day intensive care unit stay, and, on average, a 3-day hospitalization, all of which drive increased morbidity and cost. The LIFE Study provides a forum to capture the benefits of adopting a fast-track clinical protocol in appropriate patients and will provide evidence of its value across a diverse group of stakeholders. I am excited to partner with TriVascular in this important study.”

Dr. Krajcer added, “EVAR via the fast-track protocol utilizes less invasive measures that, collectively, may lower perioperative and postprocedure costs, while improving patient outcomes compared to traditional EVAR. For our hospital, the LIFE study promises strong clinical outcomes and increased patient satisfaction while using fewer resources. I believe this study will play an important role in shaping the future of EVAR therapy.”