SANTA ROSA, Calif., Aug. 3, 2015 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (NASDAQ:TRIV), manufacturer of the Ovation Abdominal Stent Graft platform, announced today two major clinical milestones: surpassing 100 patients enrolled in the Least Invasive Fast-Track EVAR (LIFE) study and completion of patient enrollment in the U.S. Post Approval Study. These achievements demonstrate the Company's ongoing commitment to significantly advance endovascular aortic repair (EVAR) of abdominal aortic aneurysms.
The LIFE study is designed to evaluate clinical outcomes and healthcare economic data on patients treated with the Ovation system utilizing the Fast-Track treatment protocol. Under Fast-Track, vessel access is gained via a bilateral percutaneous approach, local or regional anesthesia is utilized, ICU admission post-procedure is avoided and the patient is discharged the following day. This patient-friendly, resource-efficient treatment pathway is enabled by the Ovation system and has the potential to meaningfully improve the practice of EVAR. The LIFE Study is led by co-national principal investigators Zvonimir Krajcer, MD, FACC, Co-Director, Peripheral Vascular Disease Service at Texas Heart Institute in Houston, Texas and Venkatesh G. Ramaiah, MD, FACS, Director of Research at the Arizona Heart Institute and Medical Director of the Arizona Heart Hospital in Phoenix, Arizona.
"The Ovation system's low profile, and proven clinical value, when combined with less invasive percutaneous access and the potential to avoid general anesthesia, should yield excellent patient outcomes with lower costs, shorter procedures and high patient satisfaction," said Dr. Krajcer. "Dr. Ramaiah and I are excited to partner with TriVascular on this important registry. The results of the LIFE study will significantly contribute to the existing literature and add momentum to the inevitable transition toward a fast-track, next-day discharge EVAR protocol."
TriVascular also announced today the completion of the U.S. Post Approval Study (PAS). The PAS is a prospective, multi-center study that further evaluates the safety and effectiveness of the Ovation platform in a real world clinical setting. This study augments the Ovation global pivotal trial cohort as outlined in the conditions of the premarket approval application (PMA) with subjects followed for up to five years, per the required study timeline.
"By a considerable margin, the Ovation system has the broadest indications for use of any system and, as a result, has allowed us to treat patients that are otherwise ineligible for an on-label EVAR solution," commented Syed Hussain, MD, the PAS national principal investigator, Chairman of Vascular and Endovascular Surgery at Christie Clinic and Assistant Professor of Surgery at the University of Illinois. "We are excited to have partnered with TriVascular on this important study. The ongoing results of the study will further expand the clinical evidence demonstrating the safety and effectiveness profile of the Ovation system. In our practice, the Ovation system is our frontline device."
"We are focused on developing products and providing clinical evidence to help expand EVAR access to more patients and improve EVAR outcomes for all patients," said Christopher G. Chavez, Chairman, CEO and President of TriVascular. "We are excited to have reached these major clinical milestones and are grateful to all of the study investigators who put their trust in our technology when caring for their patients."
The Ovation platform has been used in the successful treatment of over 7,000 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, our stent graft 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 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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