FDA approves Ovation iX Abdominal stent graft system for abdominal aortic aneurysm- TriVascular Technologies

TriVascular Technologies announced that the FDA approved the Ovation iX Abdominal Stent Graft System for abdominal aortic aneurysm. 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 FDA approval of the Ovation iX Abdominal Stent Graft System marks the sixth FDA approval related to the Ovation platform since September 2011.

Comment: 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.