Going into effect on Jan. 1, 2025, the approvals could increase patient access to the new hypertension treatments.
Medtronic secured a Transitional Pass-Through (TPT) payment under the Medicare Hospital Outpatient Prospective Payment System for its Symplicity Spyral renal denervation catheter. The TCT status, granted by the Centers for Medicare and Medicaid Services (CMS), applies to the Symplicity blood pressure procedure and aims to reduce cost barriers for healthcare providers.
Medtronic’s Symplicity Spyral RDN system was FDA-approved in 2023, and the TPT program is expected to expand access to this treatment option for Medicare beneficiaries for up to three years.
Recor Medical Paradise Ultrasound Renal Denervation (uRDN) system also received TPT approval. The company said the system’s TPT status acknowledges its unique design, which uses ultrasound energy to target overactive sympathetic nerves surrounding the renal arteries. Recrod’s Paradise features proprietary HydroCooling technology and delivers controlled doses of ultrasound energy to reduce hypertension. It was FDA-approved in November 2023.
The TPT designation for Medtronic and Recor Medical allows hospitals to receive incremental reimbursement payments for outpatient procedures performed with these technologies. The approvals reflect CMS’s recognition of these devices as breakthrough technologies representing significant clinical advances in managing 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.
“Very few technologies achieve this qualification, and the core goals of fostering innovation and increasing access mirror Medtronic’s desire to continue bringing Symplicity to even more patients suffering from uncontrolled high blood pressure. We look forward to continuing to work with CMS to establish coverage and expand patient access.”
Lara Barghout, president and CEO of Recor Medical, said the TPT for Recor’s ultrasound renal denervation will increase access to a hypertension treatment for people unable to control their blood pressure with lifestyle changes 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. “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 remains a critical global health issue, affecting millions worldwide. These new approvals may help broaden the availability of RDN therapies to improve patient outcomes and reduce the burden of high blood pressure on healthcare systems.
Roughly 1.28 billion people between the ages of 30 and 79 worldwide have hypertension, and nearly half are unaware they have the condition, according to the World Health Organization. The WHO describes hypertension as a major cause of premature death worldwide.
