CMS Initiates National Coverage Analysis for Renal Denervation Treatment of Hypertension

The Centers for Medicare and Medicaid Services (CMS) have initiated a National Coverage Analysis (NCA) for Renal Denervation (RDN), a medical device-based treatment for hypertension developed by Recor Medical, Inc. This analysis is the initial phase in the National Coverage Determination (NCD) process, which could lead to broader Medicare coverage for Recor’s Paradise® Ultrasound Renal Denervation (uRDN) system.

Recor Medical has been at the forefront of developing and testing the Paradise uRDN system since 2009. The system has been evaluated in three major clinical trials—RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO—involving over 500 patients with uncontrolled hypertension. These studies demonstrated the system's efficacy and safety, meeting primary endpoints with consistent positive outcomes. Additionally, Recor has launched the US Global Paradise System (GPS) Post-Approval Study to gather long-term clinical evidence from 1,000 patients.

The Paradise uRDN system, which received FDA approval in November 2023, is designed to reduce blood pressure in patients whose hypertension is not adequately controlled by lifestyle changes and medication. It employs ultrasound energy to denervate the sympathetic nerves around the renal arteries, thereby lowering blood pressure. The system includes the HydroCooling™ feature, which protects the renal artery wall during the procedure.

Recor Medical, a subsidiary of Otsuka Medical Devices Co., Ltd., continues to advance the management of hypertension through innovative treatments like the Paradise uRDN system. The company is also conducting further studies and registries in the European Union, the UK, and the US to enhance the understanding and application of this technology.