Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced their support for the Centers for Medicare and Medicaid Services’ (CMS) proposed National Coverage Determination (NCD) for Renal Denervation (RDN), a device-based therapy for patients with uncontrolled hypertension—individuals whose blood pressure cannot be properly managed with lifestyle changes and medication.
The proposed NCD, released on July 10, 2025, recommends coverage for ultrasound renal denervation (uRDN) and radiofrequency renal denervation (rfRDN) for uncontrolled hypertension. A 30-day public comment period is now open for healthcare professionals, professional societies, and industry to provide input before CMS issues its final determination in October.
“We are encouraged by CMS’s proposed decision to provide Medicare coverage for uRDN in patients with uncontrolled hypertension—a population that continues to face significant unmet need,” said Lara Barghout, CEO of Recor Medical. “This preliminary determination is a meaningful step forward in recognizing the clinical value of RDN and will aid in expanding access to the patients who need it.”
Recor has been focused on developing and testing the Paradise uRDN system for the treatment of hypertension since 2009. The RADIANCE global program studied the Paradise 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 US Global Paradise System (GPS) Post-Approval Study, which intends to collect real-world clinical evidence with long-term follow-up in 1,000 patients with uncontrolled hypertension.
The Paradise uRDN system is currently commercially available for patients in the US having received FDA approval in November 2023. It 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.
About the Paradise uRDN System: The Paradise uRDN system is a first-of-its-kind 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.
