Medtronic announced the US Centers for Medicare & Medicaid Services (CMS) has approved transitional pass-through (TPT) payment for its Symplicity Spyral renal denervation catheter.
Effective 1 January 2025, this payment will last up to three years under the Medicare Hospital Outpatient Prospective Payment System.
TPT aims to enhance patient access to new technologies, including devices granted Breakthrough Device Designations like the Symplicity Spyral RDN system.
The programme aims to enhance access to newly approved healthcare technologies that may be financially burdensome for patients.
It helps Medicare beneficiaries access critical innovations soon after US Food and Drug Administration (FDA) approval by offering additional payments to hospitals.
Additionally, the initiative allows CMS to gather essential cost data for future outpatient payment determinations.
Medtronic senior vice president and cardiovascular portfolio coronary and renal denervation business president Jason Weidman said: “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.
“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.”
Approved by the FDA in November 2023, the Medtronic Symplicity Spyral RDN System is a minimally invasive treatment for high blood pressure.
During the procedure, a doctor uses a catheter to deliver radiofrequency energy to overactive nerves near the kidneys.
The TPT approval is supported by the Medtronic SPYRAL HTN Global Clinical Program, which is a study of RDN in various patient groups, including those on medication and with different cardiovascular risks.
Last month, Medtronic released encouraging long-term data from the SPYRAL HTN-ON MED trial for its Symplicity Spyral RDN system.
In a similar development, Recor Medical and its parent company, Otsuka Medical Devices, also received TPT payment approval for the Paradise Ultrasound Renal Denervation system.
This approval provides additional reimbursement for outpatient procedures using ultrasound renal denervation for Medicare fee-for-service beneficiaries.
The TPT payment will take effect on 1 January 2025 and is expected to last up to three years.
The Paradise uRDN system is an ultrasound-based renal denervation technology designed to lower blood pressure by targeting the sympathetic nerves around the renal arteries.
