Santa Rosa, CA (PRWEB) October 08, 2012
TriVascular, Inc. today announced the Premarket Approval (PMA) of the Ovation Abdominal Stent Graft System by the U.S. Food and Drug Administration (FDA) for the treatment of abdominal aortic aneurysms (AAA). Delivered through a 14 French (4.7 mm) outer diameter catheter, Ovation is the lowest profile commercially available system for EVAR. With a broader set of indications for use (IFU) than other approved systems, Ovation expands the pool of patients eligible for EVAR.
The Ovation Abdominal Stent Graft System received CE Mark approval in August 2010. In the United States, Ovation received the first ever Humanitarian Device Exemption (HDE) approval for EVAR in November 2011. To date, over 1,000 patients worldwide have been successfully treated with the Ovation Abdominal Stent Graft System.
The Ovation IDE pivotal study included 36 sites from the U.S., Germany and Chile, with a total of 161 patients treated. There were no device related major adverse events, no aneurysm ruptures, and no conversions from EVAR to open surgical repair reported in the study. An independent imaging core laboratory reported 0% type I and type III endoleaks and 0% migration. Nearly 40% of patients treated had complex anatomies, with proximal neck lengths shorter than 10 mm, distal access vessels smaller than 6 mm, or both. The method of vessel access was left to the discretion of the physician, with 43% of patients treated percutaneously.
“I am proud to have the opportunity to work with the internationally recognized vascular experts that participated in this trial and treated a global cohort of patients with abdominal aortic aneurysms,” said Manish Mehta, MD, MPH, Director of Endovascular Services at The Vascular Institute for Health & Disease in Albany, New York, who served as the Principal Investigator for the study. “The 1-year clinical trial outcomes, particularly in patients with complex anatomies, demonstrate the excellent safety and effectiveness of the Ovation stent graft system. With Ovation’s FDA approval, we can confidently offer EVAR to more patients since we now have access to a very safe and effective low profile system.”
“We are very thankful to our investigators and clinical advisors for their guidance, trust and strong support,” said Christopher G. Chavez, Chairman, CEO and President of TriVascular, Inc. “I am very proud of our entire team for achieving this impressive milestone. This has truly been a remarkable journey inspired by the entrepreneurial spirit of our founders and driven forward by the commitment of our employees. With approval in hand, we will continue the pursuit of our goal, which is to make EVAR available to more patients and to make EVAR better for all patients.”
TriVascular is directly marketing Ovation in select European countries while actively appointing independent distributors in other international markets. With PMA approval in hand, TriVascular plans to build a direct field service organization domestically to drive patient access to Ovation in the United States.
About TriVascular, Inc. - Building upon partnerships with thought leading clinicians worldwide, TriVascular develops products to address unmet clinical needs and expand the pool of patients who are candidates for EVAR. Based in Santa Rosa, California, TriVascular offers highly talented, motivated individuals the opportunity to positively impact global healthcare.