Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced U.S. Centers for Medicare & Medicaid Services (CMS) have granted the company’s Paradise® Ultrasound Renal Denervation system a Transitional Pass-through (TPT) payment.
The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years.
In approving the TPT, CMS created a distinct device category and code (C1736: Catheter Renal Denervation, Ultrasound) for Ultrasound Renal Denervation in recognition of the differentiated technology and procedure with the Paradise uRDN System. Additional details and the notice can be found here: https://public-inspection.federalregister.gov/2024-25521.pdf
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 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.
“TPT for ultrasound renal denervation increases access to a proven device-based hypertension treatment option to patients who have been unable to achieve blood pressure control with lifestyle changes and medications alone,” said Lara Barghout, president and CEO of Recor Medical. “The granting of TPT highlights the safety and efficacy of this breakthrough device, which together demonstrated that the Paradise uRDN system met the newness and significant clinical improvement criteria. By creating a distinct Device Category, CMS have also recognized that the Paradise uRDN system is a highly differentiated technology and that there are significant differences in comparison to other technologies available in the marketplace. This is a major step forward in the reimbursement available for the Paradise uRDN system, creating additional financial support for hospitals and physicians to provide this novel and effective therapy to their uncontrolled hypertension patients.”
Hypertension, or high blood pressure, is the leading contributor to disease burden worldwide, resulting in increased cardiovascular morbidity and mortality, poor quality of life, and higher costs to health systems. The U.S. Food and Drug Administration (FDA) approved Recor’s Paradise Ultrasound Renal Denervation system for the treatment of hypertension on November 7, 2023. The Paradise uRDN system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient’s blood pressure.
