LivaNova’s Perceval sutureless aortic heart valve has received approval from the US Centers for Medicare and Medicaid Services (CMS) for a New Technology Add-on Payment (NTAP).
The Perceval valve met the CMS criteria for NTAP, including the demonstration of substantial clinical improvement over existing technologies. Beginning on Oct 1, 2017, CMS will reimburse hospitals for the Perceval valve procedure with the Medicare Severity Diagnosis Related Group (MS-DRG) payment they normally receive, plus an additional payment of up to US$6,110.23.
Clinical trial data has demonstrated the Perceval valve’s ability to optimise the overall surgical approach for cardiac surgeons through reduced procedure times, decreased postoperative complications and shorter hospital stays.
The Perceval valve is designed to be suitable for traditional surgery and also to enable minimally invasive surgical approaches through its collapsible design and sutureless deployment. Engineered to restore natural valve performance, the valve features a super-elastic stent, which is intended to adapt to the movement of the aorta during the cardiac cycle and provide excellent haemodynamics.
Perceval received US Food and Drug Administration (FDA) approval in 2016, but has been in clinical use worldwide for 10 years and studied in more than 190 publications.