Recor Medical Supports Proposed CMS National Coverage Determination of Renal Denervation for the Treatment of Hypertension
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.
About Recor Medical, Inc.
Recor Medical, headquartered in Palo Alto, Calif., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. Recor has pioneered the use of the Paradise Ultrasound Renal Denervation system for the treatment of hypertension. The Paradise uRDN system is an investigational device in Japan, is FDA approved for sale in the United States, and is CE marked and approved for sale in markets where the CE mark is accepted, per approved indications for use. Recor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise uRDN system in patients with mild-to-moderate and resistant hypertension. In addition, Recor is conducting the Global Paradise System ('GPS') Registry in the European Union and the UK, and has initiated the US GPS post-approval study in the United States.
Recor Medical
About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices Co., Ltd. engages in the global development and commercialization of medical devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices is a subsidiary of Otsuka Holdings Co., Ltd. (www.otsuka.com/en), a global healthcare company listed on the Tokyo Stock Exchange (JP 4578).
https://www.omd.otsuka.com/en/
Media ContactLisa OwensThe Mullings Group
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