TriVascular's Clinical Studies of Ovation EVAR Device Reach Milestones

August 3, 2015—TriVascular Technologies, Inc. announced it reached milestones in two clinical trials of the company’s Ovation abdominal stent graft platform for endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms. Enrollment in the LIFE (Least Invasive Fast-Track EVAR) has surpassed 100 patients, and patient enrollment in the United States postapproval study (PAS) of the Ovation platform has been completed. 

The data from these trials will join the clinical results that have been reported from both the Ovation global pivotal trial and a 501-patient European postmarket registry. Trivascular announced US Food and Drug Administration approval for Ovation in October 2012 and announced European CE Mark approval in September 2010.

According to Trivascular, the LIFE study is designed to evaluate clinical outcomes and healthcare economic data on patients treated with the Ovation system utilizing the Fast-Track treatment protocol. With the Fast-Track protocol, vessel access is gained via a bilateral percutaneous approach, local or regional anesthesia is administered, intensive care unit admission postprocedure is avoided, and the patient is discharged the following day. The company noted that the Ovation system enables this patient-friendly, resource-efficient treatment pathway.

The LIFE Study is led by conational 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 Ovation system's low profile, and proven clinical value, when combined with less-invasive percutaneous access and the potential to avoid general anesthesia, should yield excellent patient outcomes with lower costs, shorter procedures, and high patient satisfaction. Dr. Ramaiah and I are excited to partner with TriVascular on this important registry. The results of the LIFE study will significantly contribute to the existing literature and add momentum to the inevitable transition toward a fast-track, next-day discharge EVAR protocol.”

The prospective, multicenter United States PAS is evaluating the safety and effectiveness of the Ovation platform in a real-world clinical setting. This study augments the Ovation global pivotal trial cohort as outlined in the conditions of the premarket approval application (PMA) with patients followed for up to 5 years, per the required study timeline.

The PAS national principal investigator is Syed Hussain, MD, who is Chairman of Vascular and Endovascular Surgery at Christie Clinic and Assistant Professor of Surgery at the University of Illinois in Champaign, Illinois.

Dr. Hussain stated in the company’s announcement, “By a considerable margin, the Ovation system has the broadest indications for use of any system and, as a result, has allowed us to treat patients that are otherwise ineligible for an on-label EVAR solution. We are excited to have partnered with TriVascular on this important study. The ongoing results of the study will further expand the clinical evidence demonstrating the safety and effectiveness profile of the Ovation system. In our practice, the Ovation system is our frontline device.”