The Centers for Medicare and Medicaid Services (CMS) has issued a proposed national coverage determination for renal denervation, a minimally invasive procedure aimed at lowering blood pressure in patients with treatment-resistant hypertension. The decision could accelerate adoption of FDA-approved devices from Medtronic and Recor Medical, whose radiofrequency and ultrasound-based systems received approval in late 2023. Medtronic’s Symplicity Spyral and Recor’s Paradise system target overactive kidney nerve signals that contribute to high blood pressure. A CMS endorsement may open access for millions of U.S. patients with uncontrolled hypertension and serve as a major growth driver for Medtronic. Boston Scientific is also entering the space through its acquisition of SoniVie, which is developing a competing device. The CMS proposal recommends Medicare coverage for both technologies. Public comments, mostly favorable, are being reviewed ahead of a final decision expected in October. Medtronic and industry leaders have praised the move as a win for patients and innovation.
21-07-2025