First Patient Enrolled in the LIFE (Least Invasive Fast-Track EVAR) Study by Dr. Wayne Nelson, MD, RPVI
Bend, Ore. — TriVascular Technologies, Inc. (NASDAQ: TRIV) announced the first patient enrolled in the LIFE Study was treated by Wayne K. Nelson, MD, RPVI at Bend Memorial Clinic and St. Charles Bend hospital in Bend, Ore. The LIFE Study is designed to evaluate the Ovation Prime® Abdominal Stent Graft System when used in the treatment of patients with Abdominal Aortic Aneurysms (AAA) using a Fast-Track EVAR protocol. With the lowest profile FDA-approved delivery catheter (14F OD), and the broadest approved indications for use, the Ovation Prime system enables physicians to safely treat more AAA patients with a less invasive approach, thereby facilitating a resource efficient, patient friendly percutaneous intervention. The LIFE Study is led by 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.
“We are excited to enroll the first patient in the LIFE Study,” stated Dr. Nelson. “The Ovation Prime system is uniquely suited to a Fast-Track protocol due to its low profile and ease of use. Our patient recovered smoothly and went home the next day. The ability to risk stratify AAA patients and offer them a Fast-Track option is compelling for patients, physicians and the hospital. We are looking forward to continued enrollment in the LIFE Study.”
“Despite technological and clinical advancement, EVAR typically involves surgical exposure of the common femoral artery, general anesthesia, a one day ICU stay, and, on average, a three day hospitalization, all of which drive increased morbidity and cost,” commented Dr. Ramaiah. “The LIFE Study provides a forum to capture the benefits of adopting a Fast-Track clinical protocol in appropriate patients and will provide evidence of its value across a diverse group of stakeholders. I am excited to partner with TriVascular in this important study.”
The primary objectives of the LIFE Study are to demonstrate the clinical and cost benefits associated with using the Ovation Prime Abdominal Stent Graft System via a Fast-Track Protocol. Key elements of the protocol include: patient eligibility for the Ovation Prime system, bilateral percutaneous access, avoidance of general anesthesia, no ICU admission, and next day discharge. The study will enroll 250 subjects at up to 40 sites in the United States. The primary endpoint is the 30-day Major Adverse Event (MAE) rate. 830-0243-01rA
“EVAR via the Fast-Track protocol utilizes less invasive measures that, collectively, may lower perioperative and post-procedure costs while improving patient outcomes compared to traditional EVAR,” commented Dr. Krajcer. “For our hospital, the LIFE Study promises strong clinical outcomes and increased patient satisfaction while using fewer resources. I believe this study will play an important role in shaping the future of EVAR therapy.”
“We are focused on developing products that safely and significantly expand the EVAR option to more patients least invasively and more economically,” said Christopher G. Chavez, Chairman, CEO and President of TriVascular. “The LIFE Study is designed to expand evidence in support of this objective utilizing the Ovation® platform. We are excited to begin enrollment on this benchmark study and are grateful to all of the study investigators who put their trust in our technology for the care of their patients.”
The Ovation platform has been used in the successful treatment of over 5000 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 Prime system is 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.
In addition to the historical information, this press release contains forward-looking statements with respect to our business, the Ovation system, our innovative technology and our ability to expand EVAR treatment option, less invasively, 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.