Recor Medical Statement on CMS National Coverage Analysis of Renal Denervation for the Treatment of Hypertension Investing.com
Palo Alto, CA, Jan. 13, 2025 (GLOBE NEWSWIRE) — Footage Medical (TASE:), Inc. (Recor) and its parent company, Otsuka Medical Devices Co., Ltd. (Otsuka Medical Devices) announced today that the Centers for Medicare and Medicaid Services (CMS) has initiated a National Coverage Analysis (NCA) of renal denervation (RDN), a medical device-based treatment of hypertension.
The launch of the NCA is the first step in the National Coverage Determination (NCD) process toward potentially expanding coverage of Recor’s Paradise ® Ultrasound Renal Denervation (uRDN) System among Medicare beneficiaries. Recor appreciates CMS’s consideration of potential national coverage of RDN as a hypertension treatment option for Medicare beneficiaries and will continue to work closely with CMS throughout the NCD process.
Since 2009, Recor has focused on the development and testing of the Paradise uRDN system for the treatment of hypertension. 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 untreated mild to moderate hypertension, and RADIANCE-HTN TRIO , who studied patients with resistant hypertension on standardized triple antihypertensive therapy. Each trial met its mandated primary efficacy endpoint with a favorable safety profile consistently observed after ultrasound RDN treatment. Recor also initiated a post-approval US Global Paradise System (GPS) study to gather real-world clinical evidence with long-term follow-up of 1,000 patients with uncontrolled hypertension.
The Paradise uRDN System is currently commercially available for patients in the US and received FDA approval in November 2023. It is indicated to lower blood pressure as an adjunctive treatment in patients with hypertension whose blood pressure is not controlled by lifestyle changes and antihypertensive medications. appropriate way.
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 overactivity that can lead to hypertension. The Paradise uRDN system delivers two to three doses of 360-degree ultrasound energy “for seven seconds each” through the main renal arteries to the surrounding nerves. The Paradise catheter features an exclusive HydroCooling™ system, which circulates sterile water through the balloon catheter during the procedure to protect the renal artery wall.
About Recor Medical, Inc.
Recor Medical, headquartered in Palo Alto, California, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. Recor pioneered the use of the Paradise Ultrasound Renal Denervation System to treat hypertension. The Paradise uRDN system is a test device in Japan, FDA approved in the United States and CE marked. Recor reported positive results in three independent, randomized, sham-controlled studies of the Paradise uRDN system in patients with mild to moderate and resistant hypertension. In addition, Recor maintains the Global Paradise System (GPS) registry in the European Union and the United Kingdom, and has initiated the US GPS study following approval in the United States.
About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices Co., Ltd. is engaged in the global development and commercialization of medical devices that provide new therapeutic options in areas where patient needs cannot be met by pharmaceutical or other conventional treatment. 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 contact
Lisa Owens
The Mullings Group
lowens@mullingsgroup.com
+1-210-601-6647
Lara BarghoutRecor Medical+1 650 542 7700lara.barghout@recormedical.com
Source: Recor Medical
