CMS to Begin Analysis for Medtronic’s Symplicity Spyral Renal Denervation

Medtronic revealed that the Centers for Medicare & Medicaid Services (CMS) is opening a national coverage analysis (NCA) on renal denervation. This process will let the agency review and develop national care coverage policy for renal denervation procedures for people with hypertension (high blood pressure).

CMS began the NCA because of Medtronic’s request to support Medicare beneficiary access to the Symplicity Spyral renal denervation (RDN) system, which is used in the Symplicity blood pressure procedure.

The U.S. Food and Drug Administration (FDA) approved the Symplicity Spyral RDN system in November 2023. The minimally invasive procedure delivers radiofrequency (RF) energy to nerves around the kidneys that may become overactive and contribute to hypertension. According to Medtronic, Symplicity Spyral is the only commercially available RDN device with the breadth of durable, consistent, long-term data and single catheter design.

Symplicity Spyral earned Health Canada approval in March 2024, and approval from China’s National Medical Products Association (NMPA) in May 2024.

“Hypertension is a global health epidemic that impacts a wide variety of patients,” said Jason Weidman, senior vice president and president of Medtronic’s Coronary and Renal Denervation business. “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.”

CMS’ action follows Medtronic’s work with the agency to pilot the framework for the Transitional Coverage for Emerging Technologies (TCET) pathway to establish coverage for the Symplicity Spyral renal denervation system, a U.S. FDA-approved breakthrough device. As referenced in the CMS tracking sheet, the expected completion date for the national coverage analysis is October 11, 2025.