This process allows the agency to review and develop a national Medicare coverage policy for RDN procedures. CMS initiated the analysis after Medtronic requested beneficiary access support for its Symplicity Spyral RDN system.
A national coverage policy would also benefit the Recor Medical Paradise RDN system. Recor Medical received an FDA nod for Paradise in November 2023. Medtronic the second company with such approval, receiving its nod just weeks later. Both companies preivously praised CMS New Technology Add-on Payment (NTAP) program acceptance for their technologies in August.
CMS’ analysis follows Medtronic’s effort to pilot framework for the Transitional Coverage for Emerging Technologies (TCET) pathway. This would establish coverage for Symplicity Spyral. The medtech giant said CMS expects to complete its analysis on Oct. 11, 2025. Until a determination goes into effect, the company said Symplicity Spyral procedures will continue to be evaluated for coverage based on medical necessity for individual Medicare patients.
“Hypertension is a global health epidemic that impacts a wide variety of patients. As the leader in developing a minimally invasive treatment option for hypertension, Medtronic has been closely engaged with CMS to establish a national coverage pathway for Symplicity Spyral,” said Jason Weidman, SVP and president of the Coronary and Renal Denervation business at Medtronic. “We appreciate CMS’ efforts in creating new pathways to expedite access to breakthrough technologies like Symplicity Spyral and look forward to our continued partnership in developing a national coverage policy.”
Recor Medical joins Medtronic in praising CMS analysis
A separate news release from Recor Medical also announced the CMS analysis for RDN procedures.
The company says the initiation marks the first step in the National Coverage Determination (NCD) process toward potentially expanding the procedure among Medicare beneficiaries.
“Recor appreciates CMS’ consideration of potential national coverage of RDN as a hypertension treatment option for Medicare beneficiaries and will continue to work closely with CMS throughout the NCD process,” the company wrote.
