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SANTA ROSA, Calif. (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (Nasdaq:TRIV), announced today FDA-approved changes to the indication statement for the Ovation and Ovation Prime Abdominal Stent Graft Systems (Ovation system). The expanded indication for use statement eliminates the minimum aortic neck length requirement and also includes clarification on appropriate vascular access techniques. The Ovation Abdominal Stent Graft System received FDA PMA approval in October 2012. The PMA-S approval for the Ovation Prime Abdominal Stent Graft System followed in December 2012.
The Ovation system, with its unique sealing technology, is now the only FDA-approved EVAR stent graft that is not restricted by the conventional measurement of aortic neck length in its labeling. The Ovation system utilizes an innovative, polymer-filled sealing ring that does not exert chronic outward force, and protects the aortic neck from dilatation by insulating it from the force of blood pressure. Unlike conventional self-expanding stent grafts, the Ovation system does not require a minimum length of parallel vessel walls in order to achieve aneurysm seal. The sealing ring provides circumferential seal at a specified location in the aorta. The clarified indication statement provides that the Ovation system may be used when the inner wall diameter is no less than 16mm and no greater than 30 mm at 13 mm below the inferior renal artery. Neck length is only considered in assessing angulation: patients with a proximal neck length of less than 10mm are indicated with an aortic angle of less than or equal to 45 degrees; otherwise angles up to 60 degrees are indicated.
"I am pleased to see the recent update to the Ovation system indications for use. This provides support that TriVascular's innovative sealing ring technology is very different from conventional stent grafts, and provides the less invasive solution, even in patients with hostile aortic neck anatomy," commented Manish Mehta, MD, MPH, Director of Endovascular Services at the Vascular Institute for Health & Disease in Albany, New York who was the principal investigator for the Ovation pivotal clinical trial. "The pivotal trial clinical results out to 2 years are excellent, and include data demonstrating complete absence of aortic neck dilatation."
The expanded indication statement also includes a clarification that both percutaneous access and femoral cutdown are appropriate vascular access techniques. The option for either percutaneous or femoral cutdown was already approved in the prior Indications for Use. This change includes the word percutaneous directly in the indication statement. Examining an available database of 43,000 patient scans, 85% of those patients had an aortic neck length and access vessel diameter within the Ovation system's revised indication statement.
"The recent approval from the FDA serves as a testament to the novel, innovative approach that the Ovation system offers and serves to increase the patient population suitable for EVAR with the Ovation system," said Christopher G. Chavez, Chairman, CEO and President of TriVascular. "Based on a minimum neck length requirement of conventional self-expanding stent grafts and their associated system profile of 18F OD or greater, the majority of diagnosed AAA patients did not have an on-label option for EVAR prior to FDA approval of the Ovation system. With the Ovation system's innovative sealing ring technology and ultra low profile 14F OD system, a majority of diagnosed AAA patients now have an on-label, clinically proven solution."
The Ovation system has been used in the successful treatment of over 3500 patients worldwide. Excellent clinical results have been reported from both the Ovation global pivotal trial and a 500-patient European Post-Market Registry. In the pre-market clinical trial, the Ovation system demonstrated 100% Freedom from Type I and III Endoleaks at two years, as well as no aortic neck dilatation through the two year mark. The Ovation and Ovation Prime systems are 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 sealing ring 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 a registration statement on Form S-1 and a related prospectus that we had filed with the SEC in connection with our initial public offering completed on April 22, 2014, 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.
Company Contact Michael Kramer Chief Financial Officer 707 543-8709 Media Contact: TriVascular Technologies, Inc Vivek K. Jayaraman VP, Global Sales & Marketing 707 543-8804
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