Medtronic announces CMS national coverage analysis for Symplicity™ Spyral Renal Denervation System

Medtronic and Renal Denervation - Medtronic announced that CMS is initiating a national coverage analysis (NCA) for renal denervation procedures, which could lead to a national Medicare coverage policy for hypertension treatment using the Symplicity™ Spyral RDN system [1] - The NCA was initiated in response to Medtronic's request to support Medicare beneficiary access to the Symplicity Spyral RDN system, a minimally invasive treatment for hypertension [1] - The expected completion date for the NCA is October 11, 2025, and until then, coverage for Symplicity blood pressure procedures will be evaluated based on medical necessity for individual Medicare patients [2] Symplicity Spyral RDN System - The Symplicity Spyral RDN system, approved by the FDA in November 2023, is a minimally invasive procedure that uses radiofrequency energy to target overactive nerves near the kidneys, which contribute to high blood pressure [3] - The system has demonstrated an 18 mmHg reduction in office blood pressure over three years in real-world settings and has the largest dataset showing long-term blood pressure reductions without additional medication [3] - The SPYRAL-HTN clinical program, involving over 4,000 patients, is the most comprehensive study of renal denervation, showing sustained blood pressure reductions in both randomized control and real-world registry trials [3] - The Symplicity RDN system is approved for commercial use in over 75 countries worldwide [3] Hypertension and Public Health Impact - Hypertension affects over 1 billion adults globally and is the leading modifiable cause of heart attack, stroke, and death [4] - Nearly 80% of adults with hypertension do not have it under control, and half of patients become non-adherent to medication within one year [4] - The national coverage analysis for renal denervation is the first of its kind for a minimally invasive, interventional treatment for high blood pressure, supported by a large public health need and robust long-term data from the SPYRAL-HTN global clinical program [5] Medtronic Overview - Medtronic is a global healthcare technology company headquartered in Galway, Ireland, with a mission to alleviate pain, restore health, and extend life [4] - The company employs over 95,000 people across more than 150 countries and develops technologies and therapies for 70 health conditions, including cardiac devices, surgical robotics, and insulin pumps [4] - Medtronic's innovative technologies aim to transform the lives of two people every second, every hour, every day [6]