Study Demonstrates Safety and Effectiveness of TriVascular's Ovation EVAR System

October 9, 2012—During a Late-Breaking Trials session at the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas, Manish Mehta, MD, presented findings from a pivotal study that sought to evaluate the safety and effectiveness outcomes of the ultra-low-profile, 14-F outer diameter (OD) Ovation abdominal stent graft system (TriVascular, Inc., Santa Rosa, CA) for endovascular repair of abdominal aortic aneurysms (AAAs). The prospective Ovation trial enrolled 161 patients from 36 sites in the US, Germany, and Chile between November 2009 and May 2011.

The Ovation abdominal stent graft system is trimodular, consisting of a 14-F OD aortic body and two iliac limbs, the smallest profile of any currently commercially available stent graft. Ovation is designed to accommodate a broader range of anatomy by addressing the two most important issues in endovascular aneurysm repair: access and seal.

According to Dr. Mehta, all Ovation study patients were treated under a common protocol. A Clinical Events Committee adjudicated adverse events, and an independent core laboratory analyzed imaging. The main inclusion criteria were proximal aortic neck length ≥ 7 mm, inner wall diameter between 16 to 30 mm, and iliac inner wall diameter between 8 and 20 mm. Despite relatively broad inclusion criteria, results of the study were positive. Technical success was achieved in 100% of cases. The 30-day major adverse event rate, the primary safety endpoint of the study, was 2.5% (4/161). AAA-related and all-cause mortality rates were 0.6% and 2.5%, respectively, through 1 year. No migration, AAA rupture, or conversion to open surgery was reported.

Of the 161 patients enrolled, 39% (63) presented with challenging anatomical characteristics, including a minimum access vessel of < 6 mm, aortic neck length < 10 mm, or both. No major adverse events were observed in this group at 30 days, and treatment success was achieved in all 63 patients at 1 year. The results of the Ovation pivotal study demonstrate the promise of this novel, ultra-low-profile, 14-F OD stent graft to expand the patient population eligible for endovascular aneurysm repair, reported Dr. Mehta.

On October 5, TriVascular announced that the Ovation system received US Food and Drug Administration premarket approval for the endovascular repair of AAAs. The device previously received approval under a humanitarian device exemption.