On October 28, 2025, CMS issued an NCD that covers FDA approved renal denervation (RDN) for uncontrolled hypertension under Coverage with Evidence Development (CED) when furnished in accordance with the coverage criteria specified in the NCD. The complete NCD decision memorandum is available on our website (see link below).
https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=318
Below is a list of studies that have been determined to meet the requirements for coverage under CED.
Study Title: The Recor Paradise System™ Hypertension Coverage With Evidence Development Study (The RADIANCE CED Study)
Sponsor: Recor Medical
Clinicaltrials.gov number: NCT07231757
CMS Approval Date: 11/21/2025
Study Title: SPYRAL CARE - Real-world Clinical Outcomes in Medicare Patients With Hypertension Treated With Symplicity Renal Denervation Plus Standard of Care Versus Standard of Care in Integrated EHR and Claims Data
Sponsor: Medtronic
Clinicaltrials.gov number: NCT07174622
CMS Approval Date: 10/30/2025