PALO ALTO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) — Recor medical (TASE:), Inc. (Recor) and its parent company, Otsuka Medical Devices Co., Ltd. Otsuka Medical Devices (Otsuka Medical Devices) announced today that the Centers for Medicare and Medicaid Services (CMS) has begun a National Coverage Analysis (NCA) of renal denervation (RDN), a medical device-based treatment for high blood pressure.
The initiation of the NCA is the first step in the National Coverage Determination (NCD) process toward potential expansion of coverage of Recor's Paradise ® Ultrasound Renal Denervation (uRDN) System among Medicare beneficiaries. Recor appreciates CMS' study of potential national coverage of RDN as a treatment option for hypertension for Medicare beneficiaries and will continue to work closely with CMS throughout the NCD process.
Recor has focused on developing and testing the Paradise uRDN system for the treatment of hypertension since 2009. The global RADIANCE program has studied the Paradise system in three independently powered, sham-controlled, randomized clinical trials in more than 500 patients with uncontrolled hypertension: RADIANCE II and RADIANCE-HTN SOLO, which studied patients with mild to moderate hypertension in an off-medication setting, and RADIANCE-HTN TRIO, which studied Patients with resistant hypertension on combined triple antihypertensive therapy. Each trial achieved its prescribed primary efficacy endpoint with an appropriate safety profile consistently observed after RDN treatment with ultrasound. Recor has also initiated a US Global Paradise System (GPS) post-approval study to collect real-world clinical evidence with long-term follow-up of 1,000 patients with uncontrolled hypertension.
The Paradise uRDN System is currently commercially available to patients in the United States after receiving FDA approval in November 2023. It is indicated for lowering blood pressure as an adjuvant treatment in hypertensive patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. .
About the Paradise uRDN system
The Paradise uRDN System is the first ultrasound-based RDN technology, designed to lower blood pressure by removing the sympathetic nerves surrounding the renal arteries, reducing excess activity that can lead to high blood pressure. The Paradise uRDN system delivers two to three doses of 360-degree ultrasound energy “lasting seven seconds each” through the main renal arteries to 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
Recor Medical, headquartered in Palo Alto, California, is a wholly-owned subsidiary of Otsuka Medical Devices Co., Ltd., a medical technology company focused on transforming the management of hypertension. Recor pioneered the use of the Paradise Ultrasound Renal Denervation System to treat high blood pressure. The Paradise uRDN System is an investigational device in Japan, FDA-approved in the United States, and carries a CE mark. Recor has reported positive results in three independent, randomized, placebo-controlled studies of the Paradise uRDN system in patients with mild to moderate, resistant hypertension. In addition, Recor is conducting a Global Positioning System (GPS) registry in the European Union and the United Kingdom, and has initiated a post-approval study of GPS in the United States.
About Otsuka Medical Devices Co., Ltd
Otsuka Medical Devices Co., Ltd. In the global development and commercialization of medical devices that provide new treatment options in areas where patient needs cannot be met by pharmaceutical or other conventional treatments. Otsuka Medical Devices is a subsidiary of Otsuka Holdings Co. (OTC:)., Ltd. (www.otsuka.com/en), a global healthcare company listed on the Tokyo Stock Exchange (JP 4578).
https://www.omd.otsuka.com/en/
Media communication
Lisa Owens
Mullings Group
lowens@mullingsgroup.com
+1-210-601-6647
Lara BarghoutRecor Medical+1 650 542 7700lara.barghout@recormedical.com
Source: Recor Medical
