Medtronic announces CMS national coverage analysis for Symplicity Spyral RDN

Medtronic (MDT) announced that the Centers for Medicare & Medicaid Services is opening a national coverage analysis 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 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 pathway to establish coverage for the Symplicity Spyral renal denervation system, a U.S. FDA-approved breakthrough device. As referenced in the CMS tracking sheet, the expected completion date for the national coverage analysis is October 11, 2025. Until a national coverage determination is put into effect, Symplicity blood pressure procedures will continue to be evaluated for coverage based on medical necessity for individual Medicare patients.