November 18, 2013—TriVascular, Inc. (Santa Rosa, CA) announced the close of a $40 million Series E Preferred Stock equity financing that the company will use to support worldwide commercialization, product development, and clinical research efforts for minimally invasive endovascular aneurysm repair (EVAR) devices.
The company is seeking to build on its Ovation and Ovation Prime platforms, which are currently available in the United States and other international markets for EVAR of abdominal aortic aneurysms (AAAs), in order to provide a minimally invasive option for patients who are not eligible for this treatment with available devices. TriVascular advised that of the estimated 2 million people in the United States with AAAs, many of these potential patients do not have access to minimally invasive, on-label EVAR because of the limitations of conventional wire-and-fabric technology. Thirty-nine percent of the patients treated in the pivotal study of the Ovation device would have been excluded from treatment in previous EVAR trials, noted the company
TriVascular’s Ovation and Ovation Prime platforms are designed to expand the on-label patient population for EVAR. They feature an ultra-low-profile (14-F outer diameter) delivery system and an innovative sealing technology.
TriVascular’s OVATION postmarket study is continuing to evaluate the safety and performance of the Ovation and Ovation Prime abdominal stents.
Among the recent milestones for the company are the October 2013 presentation by Manish Mehta, MD, of 2-year data on the Ovation pivotal study at the annual VIVA 2013: Vascular InterVentional Advances meeting in Las Vegas, Nevada. The study demonstrated 100% freedom from type I and III endoleaks, migration, rupture, or conversion to open surgical repair at both the 1- and 2-year marks. In addition, the pivotal trial cohort showed no aortic neck growth at either 1 or 2 years. In the trial, 43% of patients were treated via a percutaneous vessel access method.
In August 2013, the company announced that the 1-year results from the Ovation pivotal study were published online in the Journal of Vascular Surgery.
In July 2013, the company announced the initiation of the United States postapproval study of Ovation Prime, which received US Food and Drug Administration approval in January 2013.
In October 2012, TriVascular announced US Food and Drug Administration approval of the Ovation abdominal stent graft system device, which followed European CE Mark approval in August 2010. The Ovation platform is currently approved for sale in more than 30 countries.