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August 3, 2015

FDA Approves TriVascular's Ovation iX Abdominal Stent Graft System

August 4, 2015—TriVascular Technologies, Inc. announced that the US Food and Drug Administration approved the company’s next-generation Ovation iX “integrated exchange” abdominal stent graft system for endovascular repair of abdominal aortic aneurysms (AAA). 

According to the company, the Ovation iX’s delivery system enhancements are designed to provide additional flexibility for 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- to 13-F integrated sheath is designed to minimize vessel trauma and reduce procedural steps. The Ovation iX stent graft system also features a 14-F outer diameter.

In TriVascular’s press release, Steve Henao, MD, commented, “The improvements reflected in the new Ovation iX aortic body set the Ovation 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. 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.” Dr. Henao is a vascular surgeon at New Mexico Heart Institute in Albuquerque, New Mexico.

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August 4, 2015

CMS Reclassifies EVAR and Improves Reimbursement

August 4, 2015

CMS Reclassifies EVAR and Improves Reimbursement