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Investing.com - Medtronic , Inc. (NYSE:MDT) received positive news as the Centers for Medicare & Medicaid Services (CMS) released its proposed National Coverage Determination (NCD) for Renal Denervation (RDN) on Thursday.
The proposal establishes an ambulatory blood pressure threshold of 140 mmHg for patient eligibility, which aligns with Medtronic’s clinical trial parameters and market strategy. This threshold is equivalent to approximately 150 mmHg in office-based measurements, according to Raymond (NSE:RYMD) James analysis.
CMS did not explicitly specify how many medications a patient must be taking to qualify for the procedure, though the document defines resistant hypertension as "persistently elevated BP (NYSE:BP) above 140/90 mmHg despite management with three antihypertensive therapies of different classes." The final determination on medication requirements is expected when the rule is finalized following a 30-day comment period.
The proposal includes a required Coverage with Evidence Development (CED) study, reflecting CMS’s cautious approach due to concerns about consistent replication of clinical trial results in real-world settings and observations that approximately one-third of patients may not respond to RDN.
A final NCD is expected to be published around October 8, 2025, which would formalize reimbursement for the procedure and potentially drive broader market adoption for Medtronic’s Symplicity Spyral device, which received FDA approval in November 2023 alongside competitor Recor Medical (TASE:BLWV)’s Paradise system. With the stock trading near its 52-week high and analysts setting a consensus high target of $112.45, InvestingPro subscribers can access detailed valuation metrics and expert analysis through the exclusive Pro Research Report, available for over 1,400 US stocks.
In other recent news, Medtronic, Inc. has been the focus of significant developments following a proposed National Coverage Determination (NCD) by the Centers for Medicare & Medicaid Services (CMS) for renal denervation (RDN) therapy. The proposal aims to cover RDN for patients with uncontrolled hypertension, potentially opening a vast market opportunity for Medtronic. Analysts from William Blair, JPMorgan, BofA Securities, and BTIG have weighed in, with William Blair maintaining a Market Perform rating and JPMorgan reiterating a Neutral rating, both noting the positive implications of the CMS decision. BofA Securities holds a Buy rating, projecting that RDN therapy could contribute $100-150 million in annual revenue growth for Medtronic. The CMS proposal aligns with Medtronic’s Symplicity device, which is designed for patients whose blood pressure is not adequately controlled by lifestyle changes and medication. The coverage decision is expected to be finalized by October 2025, with the potential to create a $5-10 billion market in the U.S. alone. Medtronic is already preparing for market entry by expanding its commercial operations and training physicians. Additionally, the proposed coverage could also benefit Boston Scientific (NYSE:BSX) in the future, as they plan to launch their own RDN device.
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