TriVascular Tech Announces First Patients Treated In Europe With Ovation iX Abdominal Stent Graft System
SANTA ROSA, Calif., Sept. 15, 2015 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (NASDAQ:TRIV) announced today that the first European patients have been treated successfully with the Ovation iX Abdominal Stent Graft System in Germany and England. Building off of the clinically proven Ovation® platform, the Ovation iX System provides physicians with options for greater procedural consistency and ease of use.
With the new system, contralateral gate access can be achieved either by retrograde cannulation or through a new, built-in cross-over lumen. Cannulation of the contra-lateral limb has been a common procedural challenge during EVAR, especially when treating the growing number of patients with complex aortoiliac anatomy. TriVascular's patent-pending crossover lumen technology offers physicians an optional capability designed for easier and more predictable cannulation of the contralateral limb when they need it. The Ovation iX System received CE Mark and approval from the U.S. Food and Drug Administration (FDA) earlier this year. The first implants in Europe were performed last week at Herz- und Gefäßzentrum Bad Bevensen, Germany and Watford General Hospital, United Kingdom.
Dr. Thomas Nolte, Head of Vascular Surgery at Herz- und Gefäßzentrum Bad Bevensen, commented, "The Ovation platform, based on its breadth of application and the strength of its clinical data, is my frontline device. The new Ovation iX delivery system allows me to deploy the Ovation stent graft with increased ease and predictability. The iX system is the latest delivery system improvement from TriVascular in what is now a five year experience with the Ovation platform in Germany."
Over 1,000 patients, including the first cases completed in Europe, have been treated with the Ovation Platform in Germany since 2010. The launch of the Ovation iX Abdominal Stent Graft System demonstrates TriVascular's ongoing commitment to providing physicians with clinically valuable technologies.
The Ovation iX System will be featured at the annual DGG (Deutschen Gesellschaft für Gefäßchirurgie und Gefäßmedizin) Congress, taking place in Münster, Germany from 16th – 19th September. Dr. Nolte will be joined by Prof. Eric Verhoeven, Prof. Omke Teebken and Prof. Götz Richter for a symposium on 17 September.
The Ovation platform has been used in the successful treatment of over 7,500 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® and Ovation iX systems are 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 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.
