The U.S. Food and Drug Administration (FDA) has approved the Ovation iX iliac stent graft for the Ovation Prime abdominal stent graft system from Santa Rosa, Calif.-based TriVascular Technologies Inc. The company also has made manufacturing enhancements that officials claim will "facilitate a broader commercial launch" of the product.
Building on existing Ovation and Ovation Prime iliac technology, the Ovation iX iliac stent graft is engineered to promote patency even in "hostile" anatomy. The iX stands for integrated exchange, and the iliac stent graft 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 millimeters diameter and limb lengths up to 160 millimeters, the broader size matrix and even lower profiles enable treatment of a wider range of abdominal aortic aneurysm anatomies.
"The approval of the Ovation iX limb technology is yet another example of TriVascular's responsiveness to clinical feedback," said Syed Hussain, M.D., chairman of Vascular and Endovascular Surgery at Christie Clinic and assistant professor of surgery at the University of Illinois. "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."
"While lower profile systems have expanded the applicability of EVAR (endovascular aortic 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," said David Minion, M..D, professor of surgery and program director for vascular surgery at the University of Kentucky Medical Center. "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."
"The approval of the Ovation iX iliac stent graft further demonstrates our commitment to product innovation, expanding EVAR access to more patients and improving EVAR for all patients," said Christopher G. Chavez, Chairman, CEO and President of TriVascular. "We are dedicated to rapidly delivering new technology to enable physicians to treat more patients safely and are grateful to the many clinicians worldwide who count on us as a trusted partner in patient care."
The Ovation platform has been used in the successful treatment of approximately 7,000 patients worldwide, company officials report. Positive 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 more than 35 countries around the world.
The Ovation platform has been used in the successful treatment of approximately 7,000 patients worldwide, company officials report. Positive 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 more than 35 countries around the world.
TriVascular Technologies focuses on technology for the minimally invasive treatment of abdominal aortic aneurysms. The company claims that its Ovation Prime abdominal stent graft system is the lowest profile FDA-approved EVAR system. The system uses a novel, polymer-based sealing mechanism.