Industry News

TriVascular Receives FDA Approval for its CustomSeal Technology for Ovation Prime® System

Published on 2014-10-21. Author : SpecialChem

SANTA ROSA, Calif. -- TriVascular Technologies, Inc. (Nasdaq:TRIV) announced that the U.S. Food and Drug Administration (FDA) has approved CustomSeal Technology for the Ovation Prime System. With the Ovation Prime endograft system, physicians create a customized seal by filling the conformable O-rings with the CustomSeal polymer, effectively completing the last step of the manufacturing process in vivo. The CustomSeal technology was designed with the same biocompatible components as the Ovation Prime polymer, but now enables faster procedure times through a 30% reduction in cure time. First cases with the new sealing technology were completed by Stuart A. Harlin, MD, FACS, President, Coastal Vascular and Interventional PLLC in Pensacola, Florida and Zvonimir Krajcer, MD, FACC, Co- Director, Peripheral Vascular Disease Service at Texas Heart Institute in Houston, Texas.

"I was impressed with the performance of the CustomSeal Technology," commented Dr. Harlin. "The decrease in the polymer time provides an opportunity for reduced operative time and anesthesia exposure for our patients. Furthermore, the ability to offer our patients a customized and truly minimally invasive endovascular solution is of great value to our practice." "We are committed to rapidly delivering innovation that addresses relevant unmet clinical needs," said Christopher G. Chavez, Chairman, CEO and President of TriVascular. "The approval of the CustomSeal Technology is part of a strong cadence of product innovations designed to expand EVAR access to more patients and improve EVAR for all patients."

The Ovation® platform has been used in the successful treatment of approximately 5,000 patients worldwide. Excellent clinical results have been reported from both the Ovation global pivotal trial and a 501-patient European Post-Market Registry. Earlier this year, CustomSeal technology received CE Mark clearance and over 250 cases have been performed with CustomSeal polymer in Europe. 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.

Forward-Looking Statements

In addition to the historical information, this press release contains forward-looking statements with respect to our business, the Ovation system, its innovative sealing ring technology and the 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 its ability to successfully commercialize the products; continued market acceptance of its endovascular aortic repair systems; its ability to manufacture the endovascular systems to meet demand; the level and availability of third party payor reimbursement for its products, its ability to effectively manage its anticipated growth; its ability to protect its intellectual property rights and proprietary technologies; its ability to operate its business without infringing the intellectual property rights and proprietary technology of third parties; its ability to develop new or complementary technologies; the regulatory requirements applicable to us and its competitors; competition in its industry; additional capital and credit availability, its 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 its filings with the SEC, including its Quarterly Reports on Form 10-Q, may cause its actual results, performance or achievements to differ materially and adversely from those anticipated or implied by its forward-looking statements.The company expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

Source: TriVascular Technologies, Inc.

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