Compelling Evidence that the Ovation® System Expands and Improves Endovascular Aortic Repair to More Patients
SANTA ROSA, Calif., Nov. 3, 2015 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (NASDAQ:TRIV), manufacturer of the Ovation Abdominal Stent Graft platform, announced today the presentation of 4-year safety and effectiveness metrics from the global Ovation Pivotal Trial, during the late breaking clinical trials session at the VIVA 2015 meeting. The results were presented by Manish Mehta, MD, MPH, Director, Vascular Health Partners, CCP, President & CEO, Center for Vascular Awareness, the U.S. principal investigator for the global Ovation Pivotal Trial.
The Ovation stent graft was implanted successfully in 161 patients (100%), including 69 (42.9%) by percutaneous access. Technical success was 100%. The 30-day major adverse event rate was 2.5%. At one year, AAA-related and all-cause mortality were 0.6% and 2.5%, respectively. Major adverse event rate through one year was 6.2%. Through four years, there were no reported ruptures, conversions, Type I / III endoleaks, or migration. These results were especially compelling since nearly 40% of the patients treated would have been considered off-label for conventional self-expanding technology. Notably, the overall data continues to provide evidence of proximal aortic neck protection. The Ovation four-year data, unlike data from studies using conventional self-expanding stent grafts, show that the polymer-filled sealing rings do not provoke neck dilatation and confirm stable aortic neck diameters with the absence of type I endoleaks at four years.
"The ultra-low profile 14F OD delivery system combined with a robust aneurysm sealing technology offers an EVAR treatment option to a broader pool of patients," commented Dr. Mehta. "The four-year results of the Ovation clinical study are encouraging and suggest a safe and effective device for the treatment of AAAs. Furthermore, these data provide compelling evidence that the Ovation system can expand EVAR access to more patients and improve EVAR outcomes for all patients."
This global, prospective, multicenter, single-arm trial was conducted at 36 sites in the United States, Germany, and Chile to evaluate the safety and effectiveness of the Ovation stent graft system. From November 2009 to May 2011, 161 patients (88% males; mean age, 73 ±8 years) with AAAs (mean diameter, 54 ±9 mm) were treated with the Ovation system.
"We are excited, and proud, to share these four-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."
The midterm results of the multicenter Least Invasive Fast-Track EVAR (LIFE) registry were also presented at the late breaking clinical trials session at VIVA 2015 by Zvonimir Krajcer, MD, FACC. More information on these data and the Ovation platform can be found on http://professionals.trivascular.com/.
Last month, TriVascular announced that the first patients have been treated successfully with the Ovation iX™ Abdominal Stent Graft System. Building off of the clinically proven Ovation platform, the Ovation iX System provides physicians with options for greater procedural consistency and ease of use.
The Ovation platform has been used in the successful treatment of over 8,000 patients worldwide. Excellent clinical results have been reported from both the Ovation global pivotal trial and a 501-patient European Post-Market Registry. The Ovation platform is available for sale in over 35 countries.
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 Abdominal Stent Graft platform, the lowest profile FDA-approved EVAR system, which utilizes a novel, polymer-based sealing mechanism. TriVascular is based in Santa Rosa, California.
In addition to the historical information, this press release contains forward-looking statements with respect to our business, the Ovation system, the Ovation iX System, our stent graft technology, our clinical studies, 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 and conduct our clinical studies; 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 Annual Report on Form 10-K filed with the SEC on March 9, 2015 and our other filings with the SEC, 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.
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