Published: Mon, March 27, 2017
World | By Tasha Manning

CRG | Portfolio | Trivascular1 | Trivascular Technologies Inc. Receives Fda Approval Of The Ovation Ixtm Abd


Trivascular Technologies, Inc. Receives FDA Approval of the Ovation iX (TM) Abdominal Stent Graft System

- Next Generation Aortic Body Delivery System (NASDAQ: TRIV) today announced that it has announced that it will continue to implement the new product introductions. US Food and Drug Administration (FDA) approved the Ovation iX Abdominal Stent Graft System. Delivery system enhancements of Ovation iX, which stands for integrated exchange, are designed to provide physicians with additional flexibility for even more predictable deployment and greater ease of use. A new, built-in procedural option is available to replace retrograde cannulation of the main body device, facilitating placement of the contralateral iliac stent graft. A low profile, 12-13F integrated sheath is designed to minimize vessel trauma and reduces procedural steps. At 14F OD, the Ovation iX abdominal stent graft system remains the FDA-approved EVAR device. "The improvements reflected in the new Ovation iX aortic body set the Ovation® system even further ahead in terms of "Dr. Steve Henao, MD, Vascular Surgeon at New Mexico Heart Institute. "By providing an alternative to retrograde cannulation - there when I need it, imperceptible when I do not - the Ovation iX system offers not only excellent accuracy, but also procedural predictability. As a result, I am confident in my ability to offer my Patients consistent, high quality clinical outcomes with the Ovation system. "

"The launch of the complete Ovation iX system supports our mission to improve and safely expand EVAR for all and serves as evidence of our commitment to deliver a strong pipeline of products," said Christopher G. Chavez, Chairman, CEO and President. Of TriVascular. "We believe the Ovation iX delivery system enhancements will complement the broad IFU of the Ovation system and further enable our physician partners to provide improved, on-label EVAR treatment to more 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 global pivotal trial and the 501-patient European Post-Market Registry. The Trivascular is a medical device company developing and commercializing innovative technologies.

TriVascular Technologies, Inc.

To significantly advance minimally invasive treatment of abdominal aortic aneurysms. The company manufactures the Ovation Abdominal Stent Graft platform, the lowest FDA-approved EVAR system, which uses a novel, polymer-based sealing mechanism. TriVascular is based in Santa Rosa, California.

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TriVascular Technologies, Inc.

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Chief Financial Officer

TriVascular Technologies, Inc.

Vivek K. Jayaraman

VP, Global Sales & amp; Marketing

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