Renal denervation systems developed by Recor Medical and Medtronic have been granted transitional pass-through (TPT) payments by the Centers for Medicare and Medicaid Services (CMS) as part of the 2025 Medicare Hospital Outpatient Prospective Payment System. This financial support aims to facilitate the adoption of new medical technologies.
Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system received approval from the U.S. Food and Drug Administration (FDA) in November 2023, marking it as the first RDN system approved for treating uncontrolled hypertension. Shortly after, Medtronic’s Symplicity Spyral RDN system also gained FDA approval.
The TPT payments will begin on January 1, 2025, and can be provided for up to three years. CMS has established a new device category and code—C1736: Catheter Renal Denervation, Ultrasound—specifically for the Recor Medical system.
Lara Barghout, president and CEO of Recor Medical, emphasized the significance of this development. “TPT for ultrasound renal denervation increases access to a proven device-based hypertension treatment option for patients who struggle to control their blood pressure through lifestyle changes and medications alone,” she stated.
Barghout noted that the approval highlights the safety and effectiveness of the Paradise Ultrasound RDN system, which meets criteria for newness and significant clinical improvement. She added that CMS’s creation of a distinct device category recognizes the unique technology of the Paradise system compared to existing options.
Medtronic’s Symplicity Spyral RDN system employs radiofrequency energy to reduce excessive nerve activity linked to kidney function.
Jason Weidman, senior vice president and president of Medtronic’s coronary and RDN business, commented on the TPT approval. “This is an important milestone for our RDN catheter, as it will enhance patient access to a breakthrough treatment by lowering cost barriers for healthcare systems,” he said. Weidman highlighted that few technologies achieve this level of qualification and expressed Medtronic’s commitment to expanding access to Symplicity for patients with uncontrolled high blood pressure.
The approval of these renal denervation systems represents a significant advancement in hypertension treatment options, offering hope to patients who have not achieved adequate blood pressure control through traditional methods.
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