Medtronic announces CMS national coverage analysis for Symplicity™ Spyral Renal Denervation System
Medtronic (NYSE: MDT) announced that the Centers for Medicare & Medicaid Services (CMS) is initiating a national coverage analysis (NCA) for renal denervation procedures for hypertension patients. This analysis will help develop a national Medicare coverage policy for the Symplicity™ Spyral renal denervation system, a minimally invasive treatment for high blood pressure.
The NCA was initiated in response to Medtronic's request to support Medicare beneficiary access to the system. This follows Medtronic's collaboration with CMS on the Transitional Coverage for Emerging Technologies (TCET) pathway for the FDA-approved breakthrough device. The expected completion date for the national coverage analysis is October 11, 2025. Until then, Symplicity blood pressure procedures will continue to be evaluated for coverage based on individual Medicare patient medical necessity.
Medtronic (NYSE: MDT) ha annunciato che i Centers for Medicare & Medicaid Services (CMS) stanno avviando un'analisi nazionale della copertura (NCA) per le procedure di denervazione renale per pazienti affetti da ipertensione. Questa analisi aiuterà a sviluppare una politica nazionale di copertura Medicare per il Symplicity™ Spyral renal denervation system, un trattamento minimamente invasivo per l'ipertensione.
L'NCA è stata avviata in risposta alla richiesta di Medtronic di supportare l'accesso dei beneficiari Medicare al sistema. Questo segue la collaborazione di Medtronic con i CMS sul percorso di Copertura Transitoria per Tecnologie Emergenti (TCET) per il dispositivo innovativo approvato dalla FDA. La data di completamento prevista per l'analisi nazionale della copertura è 11 ottobre 2025. Fino ad allora, le procedure di controllo della pressione sanguigna Symplicity continueranno a essere valutate per la copertura in base all'esigenza medica individuale dei pazienti Medicare.
Medtronic (NYSE: MDT) anunció que los Centros de Servicios de Medicare y Medicaid (CMS) están iniciando un análisis nacional de cobertura (NCA) para los procedimientos de denervación renal en pacientes con hipertensión. Este análisis ayudará a desarrollar una política de cobertura nacional de Medicare para el Symplicity™ Spyral renal denervation system, un tratamiento mínimamente invasivo para la presión arterial alta.
El NCA se inició en respuesta a la solicitud de Medtronic para apoyar el acceso de los beneficiarios de Medicare al sistema. Esto sigue a la colaboración de Medtronic con los CMS en el camino de Cobertura Transitoria para Tecnologías Emergentes (TCET) para el dispositivo innovador aprobado por la FDA. La fecha prevista de finalización del análisis nacional de cobertura es 11 de octubre de 2025. Hasta entonces, los procedimientos de control de presión arterial Symplicity continuarán siendo evaluados para cobertura según la necesidad médica individual de los pacientes de Medicare.
메드트로닉 (NYSE: MDT)은 메디케어 및 메디케이드 서비스 센터(CMS)가 고혈압 환자를 위한 신장 절제술 절차에 대한 국가 커버리지 분석(NCA)을 시작한다고 발표했습니다. 이 분석은 심플리시티™ 스파이럴 신장 절제술 시스템에 대한 국가 메디케어 커버리지 정책을 개발하는 데 도움이 될 것입니다. 이는 고혈압을 위한 최소 침습적 치료법입니다.
NCA는 메드트로닉의 요청에 따라 메디케어 수혜자가 이 시스템에 접근할 수 있도록 지원하기 위해 시작되었습니다. 이는 메드트로닉이 FDA의 혁신적인 장치에 대한 전환적 기술 커버리지(TCET) 경로에서 CMS와 협력한 것에 따른 것입니다. 국가 커버리지 분석의 예상 완료일은 2025년 10월 11일입니다. 그때까지 심플리시티 혈압 절차는 개별 메디케어 환자의 의료 필요성에 따라 커버리지 평가를 계속 받게 될 것입니다.
Medtronic (NYSE: MDT) a annoncé que les Centers for Medicare & Medicaid Services (CMS) lancent une analyse nationale de couverture (NCA) pour les procédures de dénervation rénale chez les patients hypertendus. Cette analyse contribuera à élaborer une politique nationale de couverture Medicare pour le Symplicity™ Spyral renal denervation system, un traitement peu invasif contre l'hypertension.
L'NCA a été initiée en réponse à la demande de Medtronic pour soutenir l'accès des bénéficiaires Medicare au système. Cela fait suite à la collaboration de Medtronic avec les CMS sur le chemin de Couverture Transitoire pour les Technologies Émergentes (TCET) pour le dispositif révolutionnaire approuvé par la FDA. La date d'achèvement prévue pour l'analyse nationale de couverture est le 11 octobre 2025. D'ici là, les procédures de contrôle de la pression artérielle Symplicity continueront d'être évaluées pour la couverture en fonction de la nécessité médicale individuelle des patients Medicare.
Medtronic (NYSE: MDT) gab bekannt, dass die Centers for Medicare & Medicaid Services (CMS) eine nationale Deckungsanalyse (NCA) für Nieren-Denervationsverfahren bei Hypertonie-Patienten einleiten. Diese Analyse wird dabei helfen, eine nationale Medicare-Deckungspolitik für das Symplicity™ Spyral renal denervation system zu entwickeln, ein minimalinvasives Verfahren zur Behandlung von Bluthochdruck.
Die NCA wurde auf Anfrage von Medtronic initiiert, um den Zugang für Medicare-Begünstigte zu dem System zu unterstützen. Dies folgt auf die Zusammenarbeit von Medtronic mit den CMS im Rahmen des Transitional Coverage for Emerging Technologies (TCET)-Weges für das von der FDA genehmigte bahnbrechende Gerät. Das voraussichtliche Abschlussdatum für die nationale Deckungsanalyse ist der 11. Oktober 2025. Bis dahin werden die Symplicity Blutdruckverfahren weiterhin auf Basis der individuellen medizinischen Notwendigkeit der Patienten bei Medicare auf Deckung bewertet.
- CMS initiating national coverage analysis for Symplicity Spyral system, potentially expanding Medicare coverage
- Product already has FDA breakthrough device designation
- Potential access to large Medicare beneficiary market for hypertension treatment
- Coverage determination process extends until October 2025, delaying assured reimbursement
- Current coverage to case-by-case medical necessity evaluation
Insights
The CMS national coverage analysis for Medtronic's Symplicity Spyral RDN system represents a critical regulatory milestone that could significantly impact Medicare reimbursement accessibility. The TCET pathway pilot framework signals CMS's evolving approach to breakthrough device coverage, potentially accelerating market access for innovative medical technologies.
A favorable national coverage determination would establish standardized reimbursement criteria, replacing the current case-by-case medical necessity evaluations. This could substantially expand the addressable market for Medtronic's RDN technology among the Medicare population, where hypertension prevalence is particularly high.
For investors, this regulatory development carries strategic importance - a positive NCD could drive meaningful revenue growth in Medtronic's Cardiovascular Portfolio, given the large untapped market for drug-resistant hypertension treatment. The 9-month review timeline suggests potential implementation by late 2025, though interim coverage pathways remain available.
The initiation of an NCA for Symplicity Spyral positions Medtronic advantageously in the emerging renal denervation market. As the first company to potentially secure national Medicare coverage for RDN, Medtronic could establish significant first-mover advantages in provider adoption and payer relationships.
The timing aligns strategically with ongoing market development efforts following FDA approval. A streamlined national coverage pathway would accelerate institutional adoption by reducing reimbursement uncertainty - a critical barrier for novel medical technologies. The breakthrough device designation and TCET pilot participation further validate the technology's potential to address unmet clinical needs in hypertension management.
Think of this as laying down the financial infrastructure before building a house - without clear reimbursement pathways, even breakthrough technologies struggle to achieve widespread clinical implementation. This CMS review could be the catalyst needed to unlock the full commercial potential of renal denervation therapy.
- National coverage analysis is the first-of-its kind for a minimally invasive, interventional treatment for high blood pressure
- Milestone is supported by large public health need and robust, long-term data from the SPYRAL-HTN global clinical program
GALWAY,
"Hypertension is a global health epidemic that impacts a wide variety of patients," said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. "As the leader in developing a minimally invasive treatment option for hypertension, Medtronic has been closely engaged with CMS to establish a national coverage pathway for Symplicity Spyral. We appreciate CMS' efforts in creating new pathways to expedite access to breakthrough technologies like Symplicity Spyral and look forward to our continued partnership in developing a national coverage policy."
CMS' action follows Medtronic's work with the agency to pilot the framework for the Transitional Coverage for Emerging Technologies (TCET) pathway to establish coverage for the Symplicity Spyral renal denervation system, a
About the Symplicity Spyral renal denervation procedure
The Symplicity Spyral RDN system, approved by the
The Medtronic SPYRAL HTN Global Clinical Program is the most comprehensive clinical program studying RDN in over 4,000 patients in the presence and absence of medication, and with high baseline cardiovascular risk. The Symplicity blood pressure procedure has demonstrated sustained and durable drops in blood pressure out to three years in randomized control and real-world registry trials.5-8 The Symplicity RDN system is approved for commercial use in over 75 countries around the world.
About Hypertension
Hypertension, or high blood pressure, impacts more than1 billion adults worldwide, and is the leading modifiable cause of heart attack, stroke, and death.4 Despite available treatment with medications and lifestyle changes, blood pressure remains uncontrolled for many patients. Nearly
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway,
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1 Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomized, sham-controlled trial. The Lancet. 2022; 399:1401-1410.
2 Mahfoud F, Mancia G, Schmieder RE, et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. 2023 Aug ;80(8):1759-177.
3 Kandzari DE et al. Long-term Safety and Efficacy of Radiofrequency Renal Denervation in the Presence of Antihypertensive Drugs: 24-Month Results from the SPYRAL HTN–ON MED Randomized Trial. TCT 2024
4 WHO. Hypertension fact sheet. September 13, 2019. Available at: https://www.who.int/news-room/fact-sheets/detail/hypertension. Accessed February 15, 2022.
5 Bhatt, D. et al, Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial. The Lancet. September 18, 2022. DOI:https://doi.org/10.1016/S0140-6736(22)01787-1.
6 Mahfoud, F. et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension. August 2023; DOI: 10.1161/HYPERTENSIONAHA.123.21283.
7Mahfoud, F. et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet. April 2022. https://doi.org/10.1016/S0140-6736(22)00455-X(opens new window)
8 Mahfoud, F. et al. Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range. Journal of the American College of Cardiology. November 2022. https://doi.org/10.1016/j.jacc.2022.08.802
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SOURCE Medtronic plc
FAQ
When will CMS complete the national coverage analysis for MDT's Symplicity Spyral system?
How is Medicare currently covering MDT's Symplicity blood pressure procedures?
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