Edwards Lifesciences has announced that the FDA has issued approval for its INSPIRIS RESILIA prosthetic aortic valve, which is based on the popular Carpentier-Edwards PERIMOUNT device. Cleared in Europe just under a year ago, the INSPIRIS RESILIA features flaps made from RESILIA material, a tissue developed by Edwards that helps maintain the integrity of the valve while minimizing calcification. The additional advantage of RESILIA is that it comes ready to use, which means the valve is packaged dry and prepped for implantation.
The mechanics of the valve are powered by VFit technology that helps to create a good seal thanks to its unique expandable frame. The frame also has radiopaque markers to see it well under a fluoroscope, and a design that gives consideration to potential valve-in-valve procedures in the future.
The new approval was based on the same study that the European authorities based their judgement on. As Edwards explains:
Approval of the INSPIRIS valve is supported by the COMMENCE pivotal trial. Published in the European Journal of Cardio-Thoracic Surgery, two-year data of 689 patients from the COMMENCE trial showed no cases of structural valve deterioration, valve thrombosis or nonstructural valve dysfunction. In addition, the European RESILIA tissue feasibility study, which initiated enrollment in 2011, underscores the safety and effectiveness of the RESILIA tissue. Four-year results from the European feasibility study will be presented at the 31st European Association for Cardio-Thoracic Surgery’s (EACTS) annual meeting in October.
Product page: INSPIRIS RESILIA Aortic Valve…