Medtronic has obtained the Centers for Medicare & Medicaid Services (CMS) transitional pass-through (TPT) payment for the Symplicity Spyral renal denervation (RDN) catheter.
Set to be effective from 1 January 2025, the TPT payment has been granted for the catheter, which is used in the Symplicity blood pressure procedure, under the Medicare Hospital Outpatient Prospective Payment System.
This decision facilitates patient access to the hypertension treatment device, which has received breakthrough device designation from the US Food and Drug Administration (FDA).
The TPT programme is designed to encourage the use of newly approved technologies by providing additional payments to hospitals to cover costs.
This support is crucial for Medicare beneficiaries to gain access to healthcare innovations soon after the FDA approval.
The programme also allows CMS to gather cost data for future outpatient payments.Hypertension is a significant health concern, leading to heart attacks, strokes, and deaths, particularly in underserved populations in the US.
The TPT payment aims to improve access to advanced treatment options like the Symplicity Spyral RDN system, which may help patients better manage their blood pressure.
Medtronic cardiovascular portfolio, coronary and renal denervation business senior vice-president and 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.”
The FDA approved the Medtronic Symplicity Spyral RDN System in November 2023.
It is a minimally invasive procedure that targets nerves near the kidneys that are responsible for high blood pressure. It involves inserting a catheter into the renal artery and delivering radiofrequency energy to calm overactive nerves, without leaving any implant behind.The SPYRAL HTN Global Clinical Program supports the TPT approval, representing a comprehensive study of RDN with and without medication across various cardiovascular risk levels.
Last month, Medtronic revealed new long-term outcomes from its SPYRAL HTN-ON MED trial, demonstrating significant blood pressure reductions in patients treated with the Symplicity Spyral RDN system.
The system is commercially available in over 75 countries and has been used in more than 25,000 patients worldwide. However, it remains investigational in Japan.