Medtronic and Recor Medical have both received separate Medicare reimbursement approvals for their respective renal denervation (RDN) technologies. The approvals, set to take effect on January 1, 2025, are poised to expand patient access to these novel hypertension treatments.
Medtronic's Symplicity Spyral renal denervation catheter has been granted a Transitional Pass-Through (TPT) payment under the Medicare Hospital Outpatient Prospective Payment System. This status, awarded by the Centers for Medicare and Medicaid Services (CMS), aims to alleviate cost burdens for healthcare providers performing the Symplicity blood pressure procedure. The Symplicity Spyral RDN system, FDA-approved in 2023, is expected to broaden access to this treatment option for Medicare beneficiaries for up to three years.
Recor Medical's Paradise Ultrasound Renal Denervation (uRDN) system has also secured TPT approval. The company highlights that the system's TPT status acknowledges its distinctive design, which employs ultrasound energy to target overactive sympathetic nerves surrounding the renal arteries. Paradise incorporates proprietary HydroCooling technology and delivers controlled doses of ultrasound energy to mitigate hypertension. It received FDA approval in November 2023.
The TPT designation for both Medtronic and Recor Medical enables hospitals to receive incremental reimbursement payments for outpatient procedures utilizing these technologies. These approvals underscore CMS's recognition of these devices as breakthrough technologies that represent significant clinical advancements in the management of uncontrolled hypertension, a leading cause of cardiovascular disease.
"Receiving TPT approval for our RDN catheter is an important milestone for the Symplicity blood pressure procedure, as it will enable greater patient access to a breakthrough treatment by reducing cost barriers for healthcare systems," said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic.
Lara Barghout, president and CEO of Recor Medical, stated that the TPT for Recor's ultrasound renal denervation will increase access to a hypertension treatment for individuals unable to control their blood pressure through lifestyle modifications and medications alone. "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," Barghout said.
Impact on Hypertension Treatment
Hypertension remains a critical global health challenge, affecting millions worldwide. According to the World Health Organization, approximately 1.28 billion people aged 30-79 globally have hypertension, with nearly half unaware of their condition. Hypertension is a major contributor to premature death worldwide. These recent approvals have the potential to broaden the availability of RDN therapies, leading to improved patient outcomes and a reduction in the healthcare burden associated with high blood pressure.
