SANTA ROSA, Calif., Aug. 24, 2015 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (NASDAQ:TRIV), manufacturer of the Ovation® Abdominal Stent Graft platform, announced today the first patient enrolled and treated in the LUCY Study (TriVascular Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair).
The first LUCY Study patient was treated by Krishna Mannava, MD and Omar Al-Nouri, DO at Fairfield Medical Center in Lancaster, Ohio. The LUCY study is a prospective, consecutively enrolling, non-randomized multi-center post-market registry designed to evaluate the ultra-low profile (14F) Ovation platform when used in the endovascular treatment of abdominal aortic aneurysms (AAA) in female as compared to male patients. The lack of adequate treatment options, principally due to suboptimal, large bore, conventional EVAR systems, is a persistent issue for female AAA patients. Clinical literature shows that women diagnosed with AAA experience aortic expansion at a rate that is 40-80% faster than men, which can result in aortic rupture at smaller diameters. On average, women with abdominal aortic aneurysms have challenging access vessel anatomy and, often, hostile aortic neck anatomy. This fact, when combined with the technical limitations of conventional stent graft systems, results in significantly decreased access to on-label EVAR treatment for most women.
"We are excited to participate in this important study," stated Dr. Mannava. "The Ovation system is ideally suited for patients with small-diameter access vessels and diseased aortic necks, which is often characteristic of female patients. Our first LUCY case went well and we are excited to continue enrolling and, ultimately, see the results from this landmark study."
The LUCY Study is led by a five-physician advisory board, consisting of:
- Jennifer Ash, MD, Christie Clinic Vein & Vascular Center; and Asst. Clinical Prof. of Surgery University of Illinois College of Medicine in Champaign,
- Venita Chandra, MD, Clinical Assistant Professor, Surgery-Vascular Surgery Stanford School of Medicine,
- Monica Hunter, MD, Ohio Heart and Vascular Center and Director, Critical Limb Ischemia Program at The Christ Hospital,
- Eva M Rzucidlo, MD, Associate Professor of Surgery, Geisel School of Medicine, Dartmouth; and
- Ageliki Vouyouka, MD, Associate Professor Surgery and Radiology, Mount Sinai Hospital.
"Women have traditionally been under-represented in EVAR clinical trials despite a distinct need to increase patient eligibility and identify appropriate gender specific treatment algorithms," said Dr. Ash, Chair of the LUCY Advisory Board. "I am excited to be a part of the LUCY Study which is designed to provide information that has been lacking for physicians and patients on the benefits of EVAR for women."
The primary objective of the LUCY Study is to demonstrate the clinical outcomes and benefits associated with using the Ovation Abdominal Stent Graft platform in both female and male patients, including low access-related vascular complications, low mortality rates, and high eligibility rates even in patients who tend to have small access vessel diameters and challenging aortic neck anatomy. The study will enroll up to 225 subjects (75 females in the Treatment Group and 150 males in the Control Group) in up to 45 sites in the United States. Study results will provide a comparison of female and male patient outcomes. The primary endpoint is the Major Adverse Event (MAE) rate within 30 days of the initial procedure.
"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. "The goal of the LUCY Study is to answer very important questions and ensure that gender does not limit access to life-saving technology. We are excited to begin enrollment 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 platform, 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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