Ultrasound Renal Denervation System for Hypertension Garners CMS National Coverage Determination

The Centers for Medicare and Medicaid Services (CMS) have provided a national coverage determination (NCD) for the use of renal denervation (RDN) to treat uncontrolled hypertension.

The NCD includes coverage of the Paradise Ultrasound Renal Denervation (uRDN) System, which may be utilized for patients who cannot manage hypertension with medication and lifestyle changes, according to Recor Medical, the manufacturer of the Paradise Ultrasound Renal Denervation System.

The company noted two randomized controlled trials (RCTs) have shown the efficacy and safety of the Paradise uRDN system for treating mild and moderate hypertension. Another RCT also revealed effectiveness for the adjunctive use of the Paradise uRDN System to treat resistant hypertension in patients on triple antihyperintensive therapy, according to Recor Medical.

“This CMS coverage decision represents a powerful recognition of the rigorous body of evidence supporting the Paradise uRDN system,” added Helen Reeve-Stoffer, Ph.D., the chief clinical officer for Recor Medical. “Years of clinical research have demonstrated the impact of the Paradise uRDN system in lowering blood pressure in patients with uncontrolled hypertension, one of the most persistent challenges in cardiovascular medicine.”