{"id":800253,"date":"2025-01-13T16:51:38","date_gmt":"2025-01-13T21:51:38","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system\/"},"modified":"2025-01-13T16:51:38","modified_gmt":"2025-01-13T21:51:38","slug":"medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system\/","title":{"rendered":"Medtronic announces CMS national coverage analysis for Symplicity\u2122 Spyral Renal Denervation System"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<ul type=\"disc\">\n<li>\n          <i>National coverage analysis is the first-of-its kind for a minimally invasive, interventional treatment for high blood pressure<\/i>\n        <\/li>\n<li>\n          <i>Milestone is supported by large public health need and robust, long-term data from the SPYRAL-HTN global clinical program<\/i>\n        <\/li>\n<\/ul>\n<p>\n        <span class=\"legendSpanClass\">GALWAY, <span class=\"xn-location\">Ireland<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Jan. 13, 2025<\/span><\/span> \/PRNewswire\/ &#8212; Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced\u00a0that the Centers for Medicare &amp; Medicaid Services (CMS) is opening a national coverage analysis (NCA) on renal denervation, a process that will allow the agency to review and develop a national Medicare coverage policy for renal denervation procedures for patients with hypertension. This national coverage analysis was initiated by CMS in response to Medtronic&#8217;s request to support Medicare beneficiary access to the Symplicity\u2122 Spyral renal denervation (RDN) system, used in the Symplicity blood pressure procedure.<\/p>\n<p>&#8220;Hypertension is a global health epidemic that impacts a wide variety of patients,&#8221; said <span class=\"xn-person\">Jason Weidman<\/span>, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. &#8220;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&#8217; 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.&#8221;<\/p>\n<p>CMS&#8217; action follows Medtronic&#8217;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 U.S. FDA-approved breakthrough device. As referenced in the CMS tracking sheet, the expected completion date for the national coverage analysis is <span class=\"xn-chron\">October 11, 2025<\/span>. Until a national coverage determination is put into effect, Symplicity blood pressure procedures will continue to be evaluated for coverage based on medical necessity for individual Medicare patients. \u00a0\u00a0<\/p>\n<p>\n        <b>About the Symplicity Spyral renal denervation procedure <\/b>\n      <\/p>\n<p>The Symplicity Spyral RDN system, approved by the U.S. Food and Drug Administration (FDA) in <span class=\"xn-chron\">November 2023<\/span>, is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure.\u00a0 Symplicity Spyral is the only commercially available RDN device with the breadth of durable, consistent, long-term data and single catheter design. The SPYRAL-HTN clinical program has demonstrated 18 mmHg office blood pressure reductions out to three years in a real-world setting,<sup>1<\/sup> has the longest and largest real-world registry<sup>2<\/sup> and the largest dataset showing long-term reductions without the need for additional medication.<sup>2-3<\/sup><\/p>\n<p>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.<sup>5-8<\/sup> The Symplicity RDN system is approved for commercial use in over 75 countries around the world. \u00a0<\/p>\n<p>\n        <b>About Hypertension<\/b>\u00a0<br \/>Hypertension, or high blood pressure, impacts more than1 billion adults worldwide, and is the leading modifiable cause of heart attack, stroke, and death.<sup>4<\/sup> Despite available treatment with medications and lifestyle changes, blood pressure remains uncontrolled for many patients. Nearly 80% of adults with hypertension do not have it under control<sup>1<\/sup>\u00a0and half of hypertension patients become non-adherent to medication within one year.<sup>4-5\u00a0 <\/sup><\/p>\n<p>\n        <b><br \/>\n          <u>About Medtronic<\/u><br \/>\n        <\/b>\n      <\/p>\n<p>Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, <span class=\"xn-location\">Ireland<\/span>, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission \u2014 to alleviate pain, restore health, and extend life \u2014 unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4338092-1&amp;h=1879693968&amp;u=http%3A%2F%2Fwww.medtronic.com%2F&amp;a=www.Medtronic.com\" target=\"_blank\" rel=\"nofollow\">www.Medtronic.com<\/a> and follow Medtronic on <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4338092-1&amp;h=3442064115&amp;u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fmedtronic&amp;a=LinkedIn\" target=\"_blank\" rel=\"nofollow\">LinkedIn<\/a>.<\/p>\n<p>\n        <b>Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic&#8217;s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.<\/b>\n      <\/p>\n<p>\n        <sup>1 <\/sup>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.<\/p>\n<p>\n        <sup>2<\/sup> Mahfoud F, Mancia G, Schmieder RE, et al.\u00a0Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE.\u00a0Hypertension. 2023 Aug ;80(8):1759-177.<\/p>\n<p>\n        <sup>3 <\/sup>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\u2013ON MED Randomized Trial. TCT 2024<\/p>\n<p>\n        <sup>4<\/sup>\u00a0WHO. Hypertension fact sheet. <span class=\"xn-chron\">September 13, 2019<\/span>. Available at: <a href=\"https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/hypertension\" rel=\"nofollow\">https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/hypertension<\/a>. Accessed <span class=\"xn-chron\">February 15, 2022<\/span>.<\/p>\n<p>\n        <sup>5\u00a0<\/sup>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.\u00a0September 18, 2022. DOI:<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4338092-1&amp;h=4226052329&amp;u=https%3A%2F%2Fdoi.org%2F10.1016%2FS0140-6736&amp;a=https%3A%2F%2Fdoi.org%2F10.1016%2FS0140-6736\" target=\"_blank\" rel=\"nofollow\">https:\/\/doi.org\/10.1016\/S0140-6736<\/a>(22)01787-1.<\/p>\n<p>\n        <sup>6\u00a0<\/sup>Mahfoud, F. et al. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE. Hypertension.\u00a0August 2023;\u00a0 DOI: 10.1161\/HYPERTENSIONAHA.123.21283.<\/p>\n<p>\n        <sup>7<\/sup>Mahfoud, F.\u00a0 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.\u00a0April 2022.\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4338092-1&amp;h=1833794156&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3951734-1%26h%3D2212350367%26u%3Dhttps%253A%252F%252Fdoi.org%252F10.1016%252FS0140-6736(22)00455-X%26a%3Dhttps%253A%252F%252Fdoi.org%252F10.1016%252FS0140-6736(22)00455-X&amp;a=https%3A%2F%2Fdoi.org%2F10.1016%2FS0140-6736(22)00455-X(opens+new+window)\" target=\"_blank\" rel=\"nofollow\">https:\/\/doi.org\/10.1016\/S0140-6736(22)00455-X(opens new window)<\/a><\/p>\n<p>\n        <sup>8 <\/sup>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.\u00a0November 2022.\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4338092-1&amp;h=1920048834&amp;u=https%3A%2F%2Fdoi.org%2F10.1016%2Fj.jacc.2022.08.802&amp;a=https%3A%2F%2Fdoi.org%2F10.1016%2Fj.jacc.2022.08.802\" target=\"_blank\" rel=\"nofollow\">https:\/\/doi.org\/10.1016\/j.jacc.2022.08.802<\/a><\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\"><br \/>\n                  <u>Contacts:<\/u><br \/>\n                <\/span>\n              <\/p>\n<\/td>\n<td class=\"prnpr2 prnpl2 prnvab prntar prnsbtb1 prnrbrb1 prnsbbb1 prnsblb1\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n              \n            <\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Krystin\u00a0Hayward\u00a0Leong<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Ryan Weispfenning<\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Public Relations<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">Investor Relations<\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">+1-508-261-6512<\/span>\n              <\/p>\n<\/td>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" nowrap=\"nowrap\">\n<p class=\"prnml4\">\n                <span class=\"prnews_span\">+1-763-505-4626<\/span>\n              <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n<p>\u00a0<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1472\">\n<p>\n          <a href=\"https:\/\/mma.prnewswire.com\/media\/1657690\/Medtronic_Logo.html\" target=\"_blank\" rel=\"nofollow\"><br \/>\n            <img decoding=\"async\" src=\"https:\/\/mma.prnewswire.com\/media\/1657690\/Medtronic_Logo.jpg\" title=\"(PRNewsfoto\/Medtronic plc)\" alt=\"(PRNewsfoto\/Medtronic plc)\" \/><br \/>\n          <\/a>\n        <\/p>\n<\/p><\/div>\n<p>\u00a0<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder0\"><\/div>\n<p id=\"PURL\">\n        <img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=CG93587&amp;sd=2025-01-13\" \/> View original content to download multimedia:<a id=\"PRNURL\" rel=\"nofollow\" href=\"https:\/\/www.prnewswire.com\/news-releases\/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system-302349766.html\" target=\"_blank\">https:\/\/www.prnewswire.com\/news-releases\/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system-302349766.html<\/a><\/p>\n<p>SOURCE  Medtronic plc<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=CG93587&amp;Transmission_Id=202501131632PR_NEWS_USPR_____CG93587&amp;DateId=20250113\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire 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, Ireland, Jan. 13, 2025 \/PRNewswire\/ &#8212; Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced\u00a0that the Centers for Medicare &amp; Medicaid Services (CMS) is opening a national coverage analysis (NCA) on renal denervation, a process that will allow the agency to review and develop a national Medicare coverage policy for renal denervation procedures for patients with hypertension. This national coverage analysis was initiated by CMS in response to Medtronic&#8217;s request to support Medicare beneficiary access to the Symplicity\u2122 Spyral &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Medtronic announces CMS national coverage analysis for Symplicity\u2122 Spyral Renal Denervation System&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-800253","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medtronic announces CMS national coverage analysis for Symplicity\u2122 Spyral Renal Denervation System - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medtronic announces CMS national coverage analysis for Symplicity\u2122 Spyral Renal Denervation System - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire 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, Ireland, Jan. 13, 2025 \/PRNewswire\/ &#8212; Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced\u00a0that the Centers for Medicare &amp; Medicaid Services (CMS) is opening a national coverage analysis (NCA) on renal denervation, a process that will allow the agency to review and develop a national Medicare coverage policy for renal denervation procedures for patients with hypertension. This national coverage analysis was initiated by CMS in response to Medtronic&#8217;s request to support Medicare beneficiary access to the Symplicity\u2122 Spyral &hellip; Continue reading &quot;Medtronic announces CMS national coverage analysis for Symplicity\u2122 Spyral Renal Denervation System&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-01-13T21:51:38+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mma.prnewswire.com\/media\/1657690\/Medtronic_Logo.jpg\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Medtronic announces CMS national coverage analysis for Symplicity\u2122 Spyral Renal Denervation System\",\"datePublished\":\"2025-01-13T21:51:38+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system\\\/\"},\"wordCount\":1015,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mma.prnewswire.com\\\/media\\\/1657690\\\/Medtronic_Logo.jpg\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/medtronic-announces-cms-national-coverage-analysis-for-symplicity-spyral-renal-denervation-system\\\/\",\"name\":\"Medtronic announces CMS national coverage analysis for Symplicity\u2122 Spyral Renal Denervation System - 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