The Centers for Medicare & Medicaid Services (CMS) has finalised its National Coverage Determination decision, meaning both radiofrequency and ultrasound renal denervation for uncontrolled hypertension will now be covered under Medicare.
Medtronic and Recor Medical, both of which produce renal denervation devices used to treat high blood pressure, hailed the decision in press releases.
Jason Weidman, senior vice president and president of Medtronic’s coronary and renal denervation arm, said: “This milestone enables physicians to offer patients more choices when managing hypertension, potentially leading to better outcomes for a population in urgent need of new options. We congratulate CMS and recognize all the work it took to get to this point.”
Medtronic’s Symplicity Spyral radiofrequency system was approved by the U.S. Food and Drug Administration (FDA) in November 2023.
Likewise, Recor’s Paradise ultrasound renal denervation system gained approval the same month, with the company’s CEO Lara Barghout saying: “By formally recognizing the proven clinical value of renal denervation and extending Medicare coverage, CMS is paving the way for broader, more equitable access to this breakthrough therapy. This decision not only reinforces the robust body of evidence supporting the Paradise [ultrasound renal denervation] system as a safe and effective adjunctive treatment but also delivers renewed hope to patients striving for better hypertension control and improved cardiovascular health.”
