January 15, 2024- Medtronic plc announced that the Centers for Medicare & Medicaid Services (CMS) is opening a national coverage analysis (NCA) on renal denervation, a process that will allow the agency to review and develop a national Medicare coverage policy for renal denervation procedures for patients with hypertension. This national coverage analysis was initiated by CMS in response to Medtronic’s request to support Medicare beneficiary access to the Symplicity™ Spyral renal denervation (RDN) system, used in the Symplicity blood pressure procedure.
CMS’ action follows Medtronic’s work with the agency to pilot the framework for the Transitional Coverage for Emerging Technologies (TCET) pathway to establish coverage for the Symplicity Spyral renal denervation system, a U.S. FDA-approved breakthrough device.