SANTA ROSA, Calif., Sept. 12, 2014 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (Nasdaq: TRIV ) presented three-year primary safety and performance metrics from the Ovation Pivotal Trial today at the 2014 Joint Annual Meeting of the New England Vascular Society and Eastern Vascular Society. At the three-year mark, the study continued to show strong clinical results. Specifically, the data showed 100% freedom from aneurysm rupture, 100% freedom from conversion to open surgical repair, 100% freedom from Type I & III endoleaks, and 100% freedom from device migration. These results were compelling when analyzing clinically complex patient subsets. Subset analysis of patients with proximal aortic neck lengths less than 10mm, as well as patients who presented with hostile aortic neck anatomy, showed 100% freedom from: Type I and III endoleaks; rupture; migration; and conversion to surgical repair.
Notably, the data continue to provide evidence of proximal aortic neck protection. The Ovation system's polymer-filled sealing rings are designed to insulate the aortic neck from blood pressure and do not exert chronic outward force on the vessel wall. The Ovation three-year data, unlike data from studies using conventional self-expanding stent grafts, show that the mechanism of proximal sealing does not provoke neck dilatation. The results were presented by Manish Mehta, MD, MPH, Director of Endovascular Services at the Vascular Institute for Health & Disease in Albany, New York who was the principal investigator for the Ovation Pivotal Trial.
"I'm encouraged by the three-year results from the Ovation Pivotal Trial," commented Dr. Mehta. "The follow up suggests that the Ovation system is an important addition to the treatment tool kit for EVAR practitioners. The safety and performance metrics are compelling across a broad range of patients, but especially so when you consider the clinical complexity of this study's patient cohort. Many of the patients treated in the trial would not be eligible for on-label EVAR prior to the Ovation platform. I look forward to additional trial results as patient follow up and subset analysis continues."
The Ovation Pivotal Trial enrolled 161 patients across 36 sites and three countries. A further 77 patients were treated in a Continued Access arm at 28 sites in the United States. In the pivotal study cohort, nearly 40% of the patients treated would be considered off-label for conventional stent graft technology.
"We are excited, and proud, to share these three-year Ovation trial results," said Christopher G. Chavez, Chairman, CEO and President of TriVascular. "TriVascular is committed to clinical research and to providing physicians with the evidence they need to gain confidence in our technology. Ultimately, it is this confidence that will enable more patients to gain access to this less invasive, clinically proven, and life-saving therapy. Going forward, we will continue to invest in the generation of clinical data to prove, definitively, the multitude of clinical advantages offered by the Ovation platform."
The Ovation system has been used in the successful treatment of over 4,500 patients worldwide. In addition to the Ovation Pivotal Trial, excellent clinical results have been reported from a 501-patient European Post-Market Registry. The Ovation and Ovation Prime® systems are available for sale in over 25 countries around the world.
About TriVascular Technologies, Inc. - TriVascular is a medical device company developing and commercializing innovative technologies to significantly advance minimally invasive treatment of abdominal aortic aneurysms. The company manufactures the Ovation Prime Abdominal Stent Graft System, the lowest profile FDA-approved EVAR system, which utilizes a novel, polymer-based sealing mechanism. TriVascular is based in Santa Rosa, California.
Forward-Looking Statements
In addition to the historical information, this press release contains forward-looking statements with respect to our business, the Ovation system, our innovative sealing ring technology and our ability to expand EVAR treatment option to a broader population of patients with AAA disease . These forward-looking statements are based upon information that is currently available to us or our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including our ability to successfully commercialize our products; continued market acceptance of our endovascular aortic repair systems; our ability to manufacture our endovascular systems to meet demand; the level and availability of third party payor reimbursement for our products, our ability to effectively manage our anticipated growth; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; our ability to develop new or complementary technologies; the regulatory requirements applicable to us and our competitors; competition in our industry; additional capital and credit availability, our ability to attract and retain qualified personnel; product liability claims; and general economic and worldwide business conditions. These factors, together with those that are described in greater detail in our filings with the SEC, including our Quarterly Reports on Form 10-Q, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.
Company Contact Michael Kramer Chief Financial Officer 707 543-8709 Media Contact: TriVascular Technologies, Inc. Vivek K. Jayaraman VP, Global Sales & Marketing 707 543-8804 Investor Relations Contact: Westwicke Partners Jamar Ismail (415) 513-1280
