A new paradigm in electrophysiology: Medtronic receives FDA approval of Affera™ Mapping and Ablation System and Sphere-9™ Catheter

PR Newswire10-25

First-of-its-kind, all-in-one HD-mapping and dual energy (pulsed field and radiofrequency) ablation catheter Highly anticipated by electrophysiologists for its innovation and demonstrated safety and ...

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Now with two pulsed field ablation  offerings and a portfolio of electrophysiology solutions, Medtronic is shaping the future of arrythmia treatment today. GALWAY, Ireland, Oct. 24, 2024 /PRNewswire/ --Medtronic plc , a global leader in healthcare technology, today announced United States Food and Drug Administration  approval of the Affera Mapping and Ablation System with Sphere-9 Catheter, an all-in-one, high-density  mapping and pulsed field  and radiofrequency  ablation catheter for treatment of persistent atrial fibrillation  and for RF ablation of cavotricuspid isthmus  dependent atrial flutter.With this approval, Medtronic is now the first and only company with two PFA technologies available for patients with Afib. The PulseSelect Pulsed Field Ablation System, which was FDA approved in December 2023, offers physicians a safe, single-shot solution for pulmonary vein isolation  while the Affera Sphere-9 c","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU1551013425.SGD":"Allianz Income and Growth Cl AMg2 DIS H2-SGD","LU2756315318.SGD":"ALLIANZ INCOME AND GROWTH \"AMG\" (SGDHDG) INC A","LU1496350171.SGD":"FRANKLIN DIVERSIFIED BALANCED \"A\" (SGDHDG) ACC","LU0211331839.USD":"FRANKLIN MUTUAL GLB DISCOVERY \"A\" (USD) ACC","LU1496350502.SGD":"FRANKLIN DIVERSIFIED DYNAMIC \"A\" (SGDHDG) ACC","LU0943347566.SGD":"安联收益及增长平衡基金AM H2-SGD","LU2271345857.HKD":"ALLIANZ GLOBAL SUSTAINABILITY \"AT\" (HKD) ACC","LU1989771016.USD":"东方汇理环球老龄化投资基金 A2 Acc","MDT":"美敦力","VT":"世界全股市ETF-Vanguard","BK4585":"ETF&股票定投概念","LU1551013342.USD":"Allianz Income and Growth Cl AMg2 DIS USD","LU0208291251.USD":"FRANKLIN MUTUAL U.S. VALUE \"A\" (USD) INC","LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","IDE":"Voya Infrastructure Industrials and Materials Fund","BK4533":"AQR资本管理(全球第二大对冲基金)","LU1989772923.USD":"CPR Invest - Climate Action A2 Acc USD-H","LU1162221912.USD":"FRANKLIN INCOME \"A\" (USD) ACC","LU0868494708.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) INC","LU1989764664.SGD":"CPR Invest - Global Disruptive Opportunities A2 Acc SGD-H","LU2089284900.SGD":"Allianz Global Sustainability Cl AM Dis H2-SGD","BK4566":"资本集团","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","LU1914381329.SGD":"Allianz Best Styles Global Equity Cl ET Acc H2-SGD","LU1989764748.USD":"东方汇理环球颠覆性机遇A2 Acc","LU0072461881.USD":"BGF US BASIC VALUE \"A2\" ACC","LU0234572021.USD":"高盛美国核心股票组合Acc","BK4082":"医疗保健设备","LU0820562030.AUD":"ALLIANZ INCOME AND GROWTH \"AMH2\" (AUDHDG) H2 INC","IE00BKVL7J92.USD":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD","LU2756315664.SGD":"ALLIANZ INCOME AND GROWTH \"AMI\" (SGDHDG) INC","IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)","PVI":"Invesco VRDO Tax-Free ETF","BK4588":"碎股","BK4550":"红杉资本持仓","LU0320765489.SGD":"FTIF - Franklin Mutual US Value A Acc SGD","IE00B3T34201.USD":"BNY MELLON GLOBAL EQUITY INCOME \"B\" (USD) INC","LU0211326755.USD":"TEMPLETON GLOBAL INCOME \"A\" (USD) ACC","HD":"家得宝","BK4083":"家庭装潢零售","RF":"地区金融","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","LU1291159041.SGD":"CPR Invest - Global Silver Age A2 Acc SGD-H","LU2089283258.USD":"安联环球可持续基金Cl AM Dis","IE00BQXX3F31.USD":"GUINNESS GLOBAL INNOVATORS \"C\" (USD) ACC","LU0976567544.SGD":"FTIF - Templeton Global Income A Mdis SGD-H1","LU1778281490.HKD":"HSBC GIF GLOBAL LOWER CARBON EQUITY \"AD\" (HKD) INC","LU0354030511.USD":"ALLSPRING  U.S. LARGE CAP GROWTH \"I\" (USD) ACC","LU2111349929.HKD":"ALLIANZ GLOBAL SUSTAINABILITY \"AM\" (HKD) INC"},"translate_title":"电生理学新范式：美敦力Affera™标测消融系统和Sphere-9™导管获FDA批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"VT":1,"RF":1,"PVI":1,"HD":1,"IDE":1,"MDT":0.9},"content_text":"First-of-its-kind, all-in-one HD-mapping and dual energy (pulsed field and radiofrequency) ablation catheter\nHighly anticipated by electrophysiologists for its innovation and demonstrated safety and efficacy as well as improved workflow and short learning curve\nNow with two pulsed field ablation (PFA) offerings and a portfolio of electrophysiology solutions, Medtronic is shaping the future of arrythmia treatment today\n\nGALWAY, Ireland, Oct. 24, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced United States Food and Drug Administration (FDA) approval of the Affera™ Mapping and Ablation System with Sphere-9™ Catheter, an all-in-one, high-density (HD) mapping and pulsed field (PF) and radiofrequency (RF) ablation catheter for treatment of persistent atrial fibrillation (AFib) and for RF ablation of cavotricuspid isthmus (CTI) dependent atrial flutter.\n\n\n\nWith this approval, Medtronic is now the first and only company with two PFA technologies available for patients with Afib. The PulseSelect™ Pulsed Field Ablation System, which was FDA approved in December 2023, offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) while the Affera Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath.\n\"The significance of this innovative technology should be underscored; Affera is a game changer for treatment of Afib and atrial flutter,\" said Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City. \"The Affera system provides physicians with one safe, effective and efficient solution to this common and increasing problem in heart disease that needs optimized solutions for patients. With a short learning curve for experienced physicians, the possibilities are boundless for the treatment of Afib.\"\nWith a trailblazing design, the Sphere-9 catheter offers physicians the option of both PF and RF energy delivery, fully integrated with the Affera Mapping and Ablation System. The Sphere-9 catheter enhances workflow efficiency for physicians while providing excellent safety and efficacy outcomes.\n\"The Affera system was designed to address procedural challenges faced by the electrophysiology community while maintaining a high standard of safety and efficacy for patients. By enabling a single transeptal, zero-fluoroscopy, and zero-exchange workflow, the Sphere-9 catheter uniquely integrates both mapping and ablation technologies, offering the flexibility to use either pulsed field or radiofrequency energy,\" said Doron Harlev, vice president of engineering for Cardiac Ablation Solutions at Medtronic and founder of Affera. \"This marks an exciting milestone for the field, with Medtronic's robust innovation pipeline poised to drive continued progress.\"\nThe approval was based on excellent results demonstrated in the pivotal SPHERE Per-AF study, an FDA Investigational Device Exemption (IDE) trial, which compared the Sphere-9 catheter with the Affera Mapping and Ablation System to the conventional Thermocool SmartTouch® SF radiofrequency ablation catheter with the Carto™*3 System. The Affera Mapping and Ablation System and Sphere-9 catheter also received CE Mark in March 2023 and was approved in Australia in September 2024. In October 2024, Medtronic announced the start of an early feasibility study to evaluate the Sphere-9 catheter for treatment of ventricular tachycardia (VT), a cardiac arrhythmia in which the lower chamber of the heart beats abnormally fast.\n\"At Medtronic, we have a 75-year tradition of bringing disruptive innovation to market, guided by our mission and commitment to address the unmet needs of patients. With the approval of Affera, we are excited to bring a novel mapping and ablation solution to clinicians that is intended to make atrial fibrillation treatment safer, more effective, and more efficient,\" said Rebecca Seidel, president of the Cardiac Ablation Solutions business, which is part of the Medtronic Cardiovascular Portfolio. \"The potential of Affera is limitless. We will continue to fulfill our commitment to innovation, including new indications, to advance cardiovascular care and improve patient outcomes.\"\nAFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide.1 Afib is a progressive disease, often beginning as paroxsymal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases2-5.\nFor more information on Affera and the Sphere-9 catheter, visit Medtronic.com.\nAbout MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, 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 — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 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 (NYSE:MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn.\nAny 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.\nReferences\n\nRoth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.\nMiyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.\nHindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.\nWolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.\nLubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126\n\nDr. Reddy is a paid consultant for Medtronic.*Thermocool SmartTouch and Carto are trademarks of Biosense Webster, Inc.\n\n\n\n\nContacts:  \n\n\n\nLeslie Williamson                        \nRyan Weispfenning \n\n\nPublic Relations                            \nInvestor Relations \n\n\n+1-612-227-5099                          \n+1-763-505-4626 \n\n\n\n\n\n\n\n\n  \n\n View original content to download multimedia:https://www.prnewswire.com/news-releases/a-new-paradigm-in-electrophysiology-medtronic-receives-fda-approval-of-affera-mapping-and-ablation-system-and-sphere-9-catheter-302286602.html\nSOURCE Medtronic plc","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2478699820"}