CMS Issues National Coverage Determination for Recor Medical’s Paradise Ultrasound Renal Denervation System for the Treatment of Hypertension

Palo Alto, CA, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), 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.

About Recor Medical, Inc.
Recor Medical, Inc., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd. headquartered in Palo Alto, Calif., is a medical technology company dedicated to transforming the management of treatment resistant hypertension through the Paradise™ Ultrasound Renal Denervation (uRDN) system. The Paradise uRDN system is FDA approved for sale in the United States, CE marked and approved in markets where the CE mark is accepted, and authorized for marketing and manufacturing in Japan, per approved indications for use. Clinical evidence for the Paradise uRDN system includes positive outcomes in three independent, randomized, sham-controlled studies in patients with mild-to-moderate and resistant hypertension. In addition, Recor is advancing real-world evidence generation through the Global Paradise System (“GPS”) Post-Market Registry initiated in the European Union and the UK, and has initiated the U.S. GPS Post-Approval Study in the United States.
http://www.recormedical.com/

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 Contact
Lisa Owens
The Mullings Group
lowens@mullingsgroup.com
+1-210-601-6647

Attachments

Lara Barghout
Recor Medical
+1 650 542 7700
lara.barghout@recormedical.com

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