Medtronic has announced that the US Centres for Medicare & Medicaid Services (CMS) has initiated a national coverage analysis (NCA) to evaluate Medicare coverage for renal denervation procedures.
The analysis specifically focuses on the Symplicity Spyral renal denervation (RDN) system, which was developed as part of the company’s Symplicity blood pressure procedure for patients with hypertension.
This regulatory development follows Medtronic’s formal request to CMS, aimed at securing Medicare access for the Symplicity Spyral RDN system.
The device received approval from the US Food and Drug Administration (FDA) in November 2023 as a breakthrough device for managing high blood pressure.
CMS has indicated that the analysis will conclude by 11 October 2025. Until a national coverage determination is in place, coverage decisions for Symplicity procedures will continue to rely on individual assessments of medical necessity.
Medtronic stated that the NCA represents a critical regulatory step in expanding access to the Symplicity Spyral system for Medicare beneficiaries.
Medtronic senior vice president and coronary and renal denervation president Jason Weidman said: “As the leader in developing a minimally invasive treatment option for hypertension, Medtronic has been closely engaged with CMS to establish a national coverage pathway for Symplicity Spyral.
“We appreciate CMS’ efforts in creating new pathways to expedite access to breakthrough technologies like Symplicity Spyral and look forward to our continued partnership in developing a national coverage policy.”
The NCA is part of Medtronic’s collaboration with CMS to pilot the Transitional Coverage for Emerging Technologies (TCET) framework, a pathway designed to expedite Medicare coverage for innovative medical devices.
The Symplicity Spyral system is a minimally invasive procedure that delivers radiofrequency energy to overactive renal nerves, which contribute to elevated blood pressure.
Clinical data from the SPYRAL-HTN global clinical programme has demonstrated significant, sustained blood pressure reductions, including an 18 mmHg drop observed over three years in real-world scenarios. The programme includes over 4,000 patients.
The SPYRAL-HTN clinical programme has demonstrated consistent results in both randomised controlled trials and real-world registry studies. These findings extend to patients with high cardiovascular risk or those not using additional antihypertensive medication.
The system is currently approved for commercial use in more than 75 countries.
In late 2024, Medtronic secured approval from the CMS for the transitional pass-through (TPT) payment for the Symplicity Spyral renal denervation catheter. This payment, which became effective on 1 January 2025, will remain in place for up to three years under the Medicare Hospital Outpatient Prospective Payment System.
