SANTA ROSA, Calif., Aug. 4, 2015 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (NASDAQ:TRIV) announced today that the U.S. 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 reduce procedural steps. At 14F OD, the Ovation iX abdominal stent graft system remains the lowest profile FDA-approved EVAR device.
"The improvements reflected in the new Ovation iX aortic body set the Ovation(R) system even further ahead in terms of ease of use and predictability of deployment. This allows me to treat both straightforward and more challenging AAA anatomies with confidence," commented Dr. Steve Henao, Vascular Surgeon at New Mexico Heart Institute. "By providing an alternative to retrograde cannulation - there when I need it, imperceptible when I don't - 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 FDA approval of the Ovation iX Abdominal Stent Graft System marks the sixth FDA approval related to the Ovation platform since September 2011. This demonstrates TriVascular's ongoing commitment to quickly providing physicians with clinically useful products. The ease-of-use enhancements incorporated into the iX aortic body delivery system, as well as the recently approved iX iliac limb technology, are a direct result of physician input and indicative of TriVascular's responsiveness to clinical feedback.
"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 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.