TriVascular Technologies Announces FDA Approval Of Ovation IX Iliac Stent Graft

(RTTNews) - TriVascular Technologies, Inc. (TRIV) announced that the U.S. Food and Drug Administration or FDA has approved the Ovation iX Iliac Stent Graft for the Ovation Prime Abdominal Stent Graft System, together with manufacturing enhancements that will facilitate a broader commercial launch of the product.

Building upon the strength of the Ovation and Ovation Prime iliac technology, the Ovation iX iliac stent graft is engineered to promote patency even in hostile anatomy. Ovation iX stands for integrated exchange, and the iliac stent graft was developed to improve physician ease of use and expand patient applicability, the company noted.

The less invasive, low-profile integrated sheath is designed to minimize vessel trauma. With flared limbs up to 28mm diameter and limb lengths up to 160mm, the broader size matrix and even lower profiles enable treatment of a wider range of AAA anatomies.

TriVascular said that the Ovation platform has been used in the successful treatment of approximately 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. As previously announced, the company had received CE Mark clearance and FDA approval for the Ovation iX iliac stent graft, and submitted supplemental regulatory filings for manufacturing improvements designed to realize efficiencies. This approval enables a broader commercial launch of the Ovation iX iliac stent graft. The Ovation Prime system is available for sale in over 35 countries around the world.