CMS grants transitional pass-through payment for Medtronic Symplicity Spyral™ renal denervation catheter

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Medtronic, a global leader in healthcare technology, announced that the Centers for Medicare & Medicaid Services (CMS) has granted transitional pass-through (TPT) payment for the Medtronic Symplicity Spyral^™ renal denervation (RDN) catheter, used in the Symplicity^™ blood pressure procedure, under the Medicare Hospital Outpatient Prospective Payment System. TPT payment, which will be effective for up to three years beginning January 1, 2025, aims to support patient access to new and innovative technology, including devices granted Breakthrough Device Designations like the Symplicity Spyral RDN system.

The purpose of the TPT program is to support access to newly approved innovative technologies where the costs to adopt them may otherwise inhibit patient access. The TPT program reduces barriers for Medicare beneficiaries to access critical healthcare innovations shortly after products receive FDA approval by providing hospitals with additional payments to cover their costs, while allowing CMS to collect necessary cost data to determine future outpatient payments.

Approved by the U.S. Food and Drug Administration (FDA) in November 2023, the Medtronic 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. After sedation, the doctor inserts a single thin tube (known as a catheter) into the artery leading to the kidney. Once the tube is in place, the doctor administers energy to the system to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind. 

Supporting TPT approval is the Medtronic SPYRAL HTN Global Clinical Program, which is the most comprehensive clinical program studying RDN in the presence and absence of medication, and in patients with both high and lower baseline cardiovascular risk. 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 renal denervation system is limited for investigational use in Japan.