Improved Patient Outcomes and Compelling Economic Data with the Ovation® Platform and a Fast-Track EndoVascular Aortic Repair (EVAR) Protocol
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 the midterm results of the multicenter Least Invasive Fast-Track EVAR (LIFE) study, during the late breaking clinical trials session at the VIVA 2015 meeting. The results were presented by Zvonimir Krajcer, MD, FACC, Co-Director, Peripheral Vascular Disease Service at Texas Heart Institute in Houston, Texas, who is one of the LIFE Study co-national principal investigators along with 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 LIFE study was initiated to determine the clinical utility and cost effectiveness of the ultra-low profile (14F OD) Ovation Abdominal Stent Graft platform when used under least invasive conditions. The study is a prospective, multicenter registry for the treatment of patients with AAA using a fast-track protocol, consisting of appropriate patient selection, bilateral percutaneous access, avoidance of general anesthesia and intensive care unit admission, and next-day discharge. Patients are enrolled and treated with EVAR if the investigator determines that the patient can meet the fast-track protocol based on medical history and aortoiliac anatomy. Following enrollment, patients remain in the study regardless of whether all components of the fast-track program are completed. Patient outcomes and resource utilization are recorded through hospital discharge and at the 30-day follow-up visit.
The primary endpoint of the study is the proportion of subjects that experience a major adverse event (MAE) within 30 days of the initial procedure. No events have been adjudicated to be an MAE and there have not been any device related serious adverse events reported to date. Secondary endpoints include treatment success, vascular access complications, technical success, hospital stay, quality of life, groin pain, as well as freedom from rupture, conversion, Type I and III endoleaks and migration. The preliminary data from the LIFE Study demonstrate improvement in procedure time and length of stay as compared to a nationwide benchmark of hospitals performing EVAR. Additional economic cost variables to be collected include costs related to anesthesia, access method, and 30-day EVAR re-intervention.
"Preliminary results of the LIFE study are encouraging and demonstrate improved patient outcomes and compelling economic data when utilizing the Ovation platform and a fast-track EVAR protocol," commented 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."
A total of 250 subjects will be enrolled in the LIFE study at up to 40 sites in the United States. To date, over 170 patients have been enrolled.
"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 this major clinical milestone for the LIFE Study and are grateful to all of the study investigators who put their trust in our technology when caring for their patients."
The four-year results of the global Ovation Pivotal Trial were also presented at the late breaking clinical trials session at VIVA 2015 by Manish Mehta, MD, MPH. 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.
Forward-Looking Statements
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.