On Wednesday, the Centers for Medicare & Medicaid Services (CMS) proposed a significant step toward broader adoption of renal denervation (RDN) by offering coverage for both radiofrequency (rfRDN) and ultrasound (uRDN) technologies for uncontrolled hypertension. This coverage would be granted under a Coverage with Evidence Development (CED) framework, requiring treatment within CMS-approved studies.
This proposal follows Medtronic Plc’s (NYSE:MDT) request for a national coverage determination for renal denervation in December 2024. RDN is a procedure that reduces activity in the renal nerves, located in the kidneys, to help lower blood pressure.
Medtronic’s Symplicity Spyral Renal Denervation System received U.S. Food and Drug Administration (FDA) premarket approval (PMA) in November 2023. With over 18 million people in the U.S. estimated to have uncontrolled hypertension (blood pressure >150 mmHg), Medtronic stands to capitalize on a potentially massive growth driver.
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William Blair analysts view this development positively, noting the tens of billions of dollars potential of this market for Medtronic. While acknowledging historically nuanced trial data, they see the proposed rule as a meaningful first step for Symplicity’s market penetration, though they seek more concrete real-world utilization data.
The proposed CMS memo outlines specific patient criteria for RDN coverage. Patients must have a confirmed diagnosis of uncontrolled high blood pressure (above 140/90 mmHg), verified through home monitoring or ambulatory tests, even after treatment. Additionally, they must have been on stable, maximum doses of recommended medications for at least three months prior to referral for renal denervation.
William Blair analyst Brandon Vazquez states these criteria are reasonable and align well with the FDA-approved label for Symplicity, supporting a generally positive outcome. “We view this as a positive update for Medtronic that takes the company one step closer to entering the RDN market after 15 years of clinical trials and investments,” Vazquez commented.
A final decision from CMS is anticipated later this year. While contributions from RDN are expected to grow gradually, analysts believe it may take several quarters to significantly impact Medtronic’s profit and loss statement. Despite this encouraging step for Medtronic’s financials, the analyst maintains a Market Perform rating for now, awaiting clearer signs of faster progress.
Price Action: MDT stock is trading higher by 0.68% to $90.01 at last check Friday.
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