The Centers for Medicare and Medicaid Services (CMS) has granted transitional pass-through (TPT) payment for Medtronic’s Symplicity Spyral renal denervation (RDN) catheter and Recor Medical’s Paradise ultrasound RDN (uRDN) system, according to press releases from the two companies.
TPT payment, which will be effective for up to three years beginning 1 January 2025, aims to support patient access to new and innovative technology.
Symplicity Spyral
Approved by the US Food and Drug Administration (FDA) in November 2023, Medtronic‘s Symplicity Spyral RDN system is a minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure.
“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, in a company press release. “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.”
Supporting TPT approval is the Medtronic SPYRAL HTN Global clinical programme, which the company claims is the most comprehensive clinical programme studying RDN in the presence and absence of medication, and in patients with both high and lower baseline cardiovascular risk.
Medtronic advises that the Symplicity Spyral RDN system is approved for commercial use in more than 75 countries around the world and is backed by experience in more than 25,000 patients treated globally with the Symplicity blood pressure procedure. The Symplicity Spyral RDN system is limited for investigational use in Japan.
Paradise
A press release from Recor Medical and its parent company, Otsuka Medical Devices, notes that 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 release details that, in approving the TPT, CMS created a distinct device category and code (C1736: Catheter Renal Denervation, Ultrasound) for uRDN in recognition of the differentiated technology and procedure with the Paradise uRDN system.
“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 chief executive officer of Recor Medical, in the company’s press release. “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 recognised 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.”
Recor Medical advises that the FDA approved the Paradise uRDN system for the treatment of hypertension on 7 November 2023.
