Recor Medical, Inc. today announced that the Centers for Medicare and Medicaid Services (CMS) has issued its National Coverage Determination (NCD) for Renal Denervation (RDN), including Recor’s Paradise® Ultrasound Renal Denervation (uRDN) system, a device-based therapy for patients with uncontrolled hypertension whose blood pressure cannot be properly managed with lifestyle changes and medication.
“I would like to commend CMS for all the effort it took to issue this NCD. This is a transformative milestone for patients across the U.S. who continue to battle uncontrolled hypertension,” said Lara Barghout, CEO of Recor Medical. “By formally recognizing the proven clinical value of renal denervation and extending Medicare coverage, CMS is paving the way for broader, more equitable access to this breakthrough therapy. This decision not only reinforces the robust body of evidence supporting the Paradise uRDN system as a safe and effective adjunctive treatment but also delivers renewed hope to patients striving for better hypertension control and improved cardiovascular health.”
“This CMS coverage decision represents a powerful recognition of the rigorous body of evidence supporting the Paradise uRDN system,” added Chief Clinical Officer Helen Reeve-Stoffer, Ph.D. “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.”
Recor has been focused on developing and testing the Paradise uRDN system as an adjunctive treatment option for uncontrolled hypertension since 2009. The RADIANCE global program studied the Paradise uRDN system in three independently powered, sham-controlled, randomized clinical trials in over 500 patients with uncontrolled hypertension: RADIANCE II and RADIANCE-HTN SOLO, which studied patients with mild-moderate hypertension in an “off-meds” setting, and RADIANCE-HTN TRIO, which studied patients with resistant hypertension on standardized triple antihypertensive therapy. Each trial met its prescribed primary efficacy endpoint with a favorable safety profile consistently observed following ultrasound RDN treatment. Recor has also initiated the U.S. Global Paradise System (GPS) Post-Approval Study, which intends to collect real-world clinical evidence with long-term follow-up in up to 1,000 patients with uncontrolled hypertension.
The Paradise uRDN system is currently commercially available for patients in the U.S., having received FDA approval in November 2023. The Paradise Ultrasound Renal Denervation system (Paradise system) is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. Potential procedure-related adverse events including pain, vascular access site complications, and vasospasm are most common. Individual results may vary.
About the Paradise uRDN System: The Paradise uRDN system is a novel ultrasound-based RDN technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension. The Paradise uRDN system delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through the main renal arteries to the surrounding nerves. The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.