Recor Medical, a subsidiary of Otsuka Medical Devices Co., Ltd., announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted its Paradise Ultrasound Renal Denervation (uRDN) system a Transitional Pass-through (TPT) payment. This decision, effective January 1, 2025, aims to increase access to this novel hypertension treatment for Medicare fee-for-service beneficiaries by providing incremental reimbursement for outpatient procedures.
The CMS approval includes the creation of a distinct device category and code (C1736: Catheter Renal Denervation, Ultrasound) specifically for the Paradise uRDN system, recognizing its unique ultrasound-based technology and procedural approach. Detailed information regarding this decision is available in the Federal Register.
How Paradise uRDN Works
The Paradise uRDN system employs a first-of-its-kind ultrasound-based technology to reduce blood pressure. It targets the sympathetic nerves surrounding the renal arteries, which, when overactive, can contribute to hypertension. The system delivers two to three doses of 360-degree ultrasound energy, each lasting seven seconds, to denervate these nerves. The Paradise catheter incorporates the HydroCooling system, circulating sterile water to protect the renal artery wall during the procedure.
Impact of TPT
Lara Barghout, president and CEO of Recor Medical, stated that the TPT will enhance patient access to a proven device-based treatment for hypertension, particularly for those who have not achieved adequate blood pressure control through lifestyle modifications and medication. She emphasized that the TPT underscores the safety and efficacy of the Paradise uRDN system, meeting the criteria for newness and significant clinical improvement. The establishment of a distinct device category by CMS further acknowledges the differentiated nature of the Paradise uRDN system compared to other available technologies. This move is expected to provide additional financial support for hospitals and physicians offering this therapy to patients with uncontrolled hypertension.
Hypertension: A Global Health Challenge
Hypertension remains a leading contributor to the global disease burden, increasing the risk of cardiovascular morbidity and mortality, diminishing quality of life, and escalating healthcare costs. The U.S. Food and Drug Administration (FDA) approved Recor’s Paradise uRDN system for hypertension treatment on November 7, 2023, as an adjunctive therapy when lifestyle changes and medications are insufficient.
About Recor Medical
Recor Medical, based in Palo Alto, California, specializes in developing innovative medical technologies for hypertension management. The Paradise uRDN system is currently under investigation in Japan, has received FDA approval in the United States, and holds the CE mark. Clinical trials have demonstrated positive outcomes in patients with mild-to-moderate and resistant hypertension. Recor is also 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.
