TriVascular's Ovation iX Iliac Stent Graft Approved for the Ovation Prime Abdominal Stent Graft System

June 15, 2015—TriVascular, Inc. announced that the US Food and Drug Administration (FDA) has approved the Ovation iX (integrated exchange) 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.

The Ovation Prime system is available for sale in more than 35 countries around the world. TriVascular previously received European CE Mark clearance and FDA approval for the Ovation iX iliac stent graft and announced the submission of supplemental regulatory filings for manufacturing improvements designed to realize efficiencies.

According to the company, the Ovation iX iliac stent graft builds upon TriVascular's Ovation and Ovation Prime iliac technology. The device, which is engineered to promote patency even in hostile anatomy, was developed to improve physician ease of use and expand patient applicability. The less-invasive, low-profile (10–13 F), integrated sheath is designed to minimize vessel trauma. With flared limbs up to 28 mm in diameter and limb lengths up to 160 mm, the broader size matrix and lower profiles enable treatment of a wider range of abdominal aortic aneurysm anatomies.

In TriVascular’s press release, Syed Hussain, MD, commented, “The approval of the Ovation iX limb technology is yet another example of TriVascular's responsiveness to clinical feedback. The integrated sheath will minimize catheter exchanges and vessel trauma. In addition, the expanded size matrix enables me to offer an endovascular repair to a broader population of my patients.” Dr. Hussain is Chairman of Vascular and Endovascular Surgery at the Christie Clinic and Assistant Professor of Surgery at the University of Illinois in Champaign, Illinois.

David Minion, MD, added, “While lower-profile systems have expanded the applicability of endovascular aneurysm repair in patients with small or diseased access vessels, concerns of reduced limb patency have surfaced in other low-profile grafts, negating much of their potential benefit. In contrast, our experience with the Ovation system, and specifically the Ovation iliac limb technology, is excellent in even the most challenging access cases. The new iX technology solidifies the Ovation system’s status as unsurpassed from top to bottom.” Dr. Minion is Professor of Surgery and Program Director for Vascular Surgery at the University of Kentucky Medical Center in Lexington, Kentucky.