Medtronic's stock is rising after the Centers for Medicare & Medicaid Services proposed coverage for renal denervation, a procedure to treat uncontrolled hypertension. The coverage would be granted under a Coverage with Evidence Development framework, requiring treatment within CMS-approved studies. Analysts view this development positively, noting the potential for tens of billions of dollars in revenue for Medtronic. A final decision from CMS is expected later this year.
Medtronic plc's stock has seen a significant increase following the Centers for Medicare & Medicaid Services (CMS) proposal for coverage of renal denervation (RDN) procedures. The proposal, which includes a Coverage with Evidence Development (CED) framework, aims to treat uncontrolled hypertension by covering the procedure for eligible patients under specific criteria. The stock has gained momentum as analysts project substantial revenue growth for Medtronic.
The CMS proposal, released on July 10, 2025, sets an ambulatory blood pressure threshold of 140 mmHg for patient eligibility. This aligns with Medtronic’s clinical trial parameters and market strategy [2]. The proposal requires patients to have persistently elevated blood pressure above 140/90 mmHg despite management with three antihypertensive therapies of different classes. A final decision is expected around October 8, 2025 [1].
Medtronic’s Symplicity Spyral™ renal denervation (RDN) system, approved by the U.S. Food and Drug Administration (FDA) in November 2023, is the focus of this proposal. The system delivers radiofrequency energy to nerves near the kidneys, contributing to high blood pressure. Clinical studies have shown significant long-term reductions in blood pressure without the need for additional medication [3].
Analysts view this development positively, noting the potential for tens of billions of dollars in revenue for Medtronic. William Blair maintains a Market Perform rating, JPMorgan reiterates a Neutral rating, and BofA Securities holds a Buy rating, projecting annual revenue growth of $100-150 million from RDN therapy [2].
Medtronic is preparing for market entry by expanding commercial operations and training physicians. The proposed coverage could also benefit Boston Scientific (NYSE:BSX), which plans to launch its own RDN device.
A final decision from CMS is expected later this year, which would formalize reimbursement for the procedure and potentially drive broader market adoption for Medtronic’s Symplicity Spyral device.
References:
[1] https://news.medtronic.com/Medtronic-issues-statement-on-the-U-S-Centers-for-Medicare-Medicaid-Services-proposed-National-Coverage-Determination-for-Symplicity-Spyral-TM-renal-denervation-RDN-system
[2] https://www.investing.com/news/analyst-ratings/medtronic-stock-gains-as-cms-proposes-renal-denervation-coverage-93CH-4132109
[3] https://www.investing.com/news/analyst-ratings/medtronic-stock-gains-as-cms-proposes-coverage-for-renal-denervation-93CH-4132451
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