ARTICLE SUMMARY:
Edwards seeks tricuspid valve coverage via FDA-CMS Parallel Review. Excerpted from Pathways’ Picks June 26: U Orphan Device Path, US Parallel Review, Global Roundup, and More.
Four months after FDA approved Edwards Lifesciences’ Evoqueas the first transcatheter tricuspid valve replacement in the US, CMS agreed on June 20 to consider the device category for national coverage. Notably, Edwards’ February letter requesting the analysis disclosed that Evoque has been accepted into the FDA-CMS Parallel Review program where both agencies provided input into the design of Edwards’ TRISCEND II pivotal trial. Since Parallel Review was piloted in 2011, only two devices have gained approval and coverage via the program. Meanwhile, CMS has been working to develop the new Transitional Coverage for Emerging Technologies (TCET) pathway, with some similar features to Parallel Review, for the past several years but has yet to finalize that policy. CMS is seeking public comment on the transcatheter tricuspid valve replacement coverage analysis by July 20.