CMS Finalizes National Coverage Determination for Renal Denervation Systems

October 29, 2025—The Centers for Medicare & Medicaid Services (CMS) has released the final National Coverage Determination (NCD) on renal denervation (RDN).

Medtronic and Recor Medical, Inc. (and its parent company, Otsuka Medical Devices Co., Ltd.) separately announced the action. The NCD is applicable to Medtronic’s Symplicity Spyral radiofrequency RDN system and Recor’s Paradise ultrasound renal denervation (uRDN) system for the treatment of uncontrolled hypertension in Medicare patients.

The complete Decision Memo is available for download on the CMS website here.

Both the Medtronic Symplicity Spyral RDN and the Recor Paradise uRDN systems were approved by the FDA in November 2023.

Jason Weidman, Senior Vice President and President of the Coronary & Renal Denervation business at Medtronic, and Recor’s Chief Clinical Officer Helen Reeve-Stoffer, PhD, commented on the NCD in the respective Medtronic and Recor press releases.

“We are very pleased with the final NCD, which opens up patient access to RDN with the Symplicity Spyral RDN system, a safe and durable blood pressure–lowering procedure for patients who have not succeeded with medication or lifestyle changes alone,” stated Weidman. “This milestone enables physicians to offer patients more choices when managing hypertension, potentially leading to better outcomes for a population in urgent need of new options. We congratulate CMS and recognize all the work it took to get to this point.”

Dr. Reeve-Stoffer stated, “This CMS coverage decision represents a powerful recognition of the rigorous body of evidence supporting the Paradise uRDN system. Years of clinical research have demonstrated the impact of the Paradise uRDN system in lowering blood pressure in patients with uncontrolled hypertension, one of the most persistent challenges in cardiovascular medicine.”