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U.S. Centers for Medicare & Medicaid Services finalizes National Coverage Determination for the Medtronic Symplicity Spyral™ renal denervation (RDN) system
Prnewswire·2025-10-28 22:36

Core Viewpoint - Medtronic's Symplicity Spyral renal denervation system is now covered by Medicare for patients with uncontrolled hypertension, enhancing access to this innovative treatment option [1][2]. Group 1: Product and Technology - The Symplicity Spyral RDN system is a minimally invasive procedure that uses radiofrequency energy to treat high blood pressure by targeting overactive nerves near the kidneys [1]. - This system has been approved for commercial use in nearly 80 countries and is available in major healthcare centers across the U.S. [2][1]. - The technology has shown sustained and durable reductions in blood pressure over three years in clinical trials, making it a unique offering in the market [3]. Group 2: Market Opportunity - The final coverage determination by CMS represents a significant opportunity for Medtronic to improve patient care and expand its market presence in hypertension treatment [1][2]. - The company aims to collaborate closely with healthcare providers to accelerate the adoption of this technology, positioning it as a key growth driver [1]. Group 3: Industry Context - Hypertension is a global health crisis, with nearly 80% of adults affected not having their condition under control, highlighting the urgent need for effective treatment options [2]. - The SPYRAL HTN global clinical program is the most comprehensive study of renal denervation, involving over 5,000 patients, which supports the efficacy of the Symplicity Spyral system [3].