{"id":62301,"date":"2025-12-04T19:06:01","date_gmt":"2025-12-04T18:06:01","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/valvosoft-the-first-non-invasive-treatment-for-severe-symptomatic-aortic-stenosis-ssas-from-cardiawave-receives-ce-marking\/"},"modified":"2025-12-04T19:06:01","modified_gmt":"2025-12-04T18:06:01","slug":"valvosoft-the-first-non-invasive-treatment-for-severe-symptomatic-aortic-stenosis-ssas-from-cardiawave-receives-ce-marking","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/valvosoft-the-first-non-invasive-treatment-for-severe-symptomatic-aortic-stenosis-ssas-from-cardiawave-receives-ce-marking\/","title":{"rendered":"VALVOSOFT\u00ae, the First Non-Invasive Treatment for Severe Symptomatic Aortic Stenosis (sSAS) from Cardiawave Receives CE Marking"},"content":{"rendered":"
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LEVALLOIS-PERRET, France–(BUSINESS WIRE)–#AorticStenosis<\/a>–Cardiawave, a pioneering medtech company developing non-invasive ultrasound therapy (NIUT) for aortic stenosis, has received CE Certificate for Valvosoft\u00ae, the world\u2019s first non-invasive therapeutic alternative to treat Severe Symptomatic Aortic Stenosis (sSAS), a serious, degenerative and fast-growing disease due to population aging, which remains without a solution for many patients around the world.\n<\/p>\n

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\n\u201cInnovating to address unmet patient needs is at the heart of Cardiawave\u2019s mission. We are therefore extremely proud to have received CE Certificate for our first-of-its-kind non-invasive ultrasound therapy (NIUT) for patients suffering from aortic valve stenosis who are not recommended for immediate valve replacement, or refusing such intervention<\/i>,\u201d said Carine Schorochoff, Chief Executive Officer and Board Director at Cardiawave.<\/b> \u00ab With CE Marking of our Valvosoft system, we can now provide a much-needed treatment option for patients<\/i>.\u201d\n<\/p>\n

\nThis approval follows the results from Cardiawave\u2019s Valvosoft\u00ae FIM Study (24 months)<\/b> and Valvosoft\u00ae Pivotal Study (12 months)<\/b> evaluating its innovative NIUT for the treatment of sSAS. Conducted in 100 elderly, highly comorbid patients across 12 European centers in 4 countries<\/b>, the studies demonstrated the feasibility, safety, and clinical benefits of the therapy. Durable improvements were observed one year after treatment, including enhanced cardiac function and significantly better patient quality of life.\n<\/p>\n

\nProf. Christian Spaulding<\/b>, Director of Interventional Cardiology, H\u00f4pital Europ\u00e9en Georges Pompidou – AP-HP – Paris, France, and Coordinating Investigator for the Valvosoft\u00ae Pivotal Study<\/b>, stated: \u201cThe Valvosoft\u00ae Pivotal Study has demonstrated a strong safety profile and has shown its ability to improve hemodynamic parameters in patients suffering from symptomatic severe aortic valve stenosis who are not eligible for immediate valve replacement. The improvements in patients\u2019 quality of life are now offering a therapy to many patients who previously had no treatment options<\/i>.\u201d\n<\/p>\n

\n\u201cValvosoft perfectly illustrates how ultrasound technology is now coming of age, both from a regulatory standpoint and in terms of patient access. The CE Marking validates the robustness of this non-invasive approach and paves the way for broader adoption in Europe and beyond. This major milestone introduces a new therapeutic option that could transform the treatment of aortic stenosis and, more broadly, cardiovascular diseases.<\/i>\u201d said Jonathan Freeman, Chairman of the Board of Directors.<\/b>\n<\/p>\n

\n\u201cValvosoft is one of the most promising innovations we have seen in the field of aortic stenosis in the past decade. Its CE Marking is a major achievement, supported by robust clinical data showing safety, feasibility, and substantial clinical improvement in elderly patients with severe aortic stenosis. A non-invasive therapy capable of improving valve function would represent a paradigm shift in how we manage aortic stenosis. The next clinical steps in North America will be crucial and potentially transformative for patient care<\/i>.\u201d comment Prof. Josep Rodes-Cabau & Prof. Philippe Pibarot, from Laval University, Canada.<\/b>\n<\/p>\n

\n\u201cThe CE Marking of Valvosoft confirms the clinical value of the approach: using therapeutic ultrasound to treat aortic stenosis in a non-invasive way. This important milestone is exciting and potentially marks the beginning of a new era in the management of valvular disease<\/i>.\u201d stated Dr Philippe G\u00e9n\u00e9reux<\/b>, Interventional Cardiologist and Director of the Structural Heart Program at the Gagnon Cardiovascular Institute at Morristown Medical Center, Morristown NJ, USA.<\/b>\n<\/p>\n

\n\u201cGiven the growing burden of aortic stenosis, an increasingly prevalent disease driven by population aging, and the clear clinical benefit of intervening before irreversible cardiac damage occurs, Valvosoft introduces a novel and highly promising therapeutic approach that could redefine how we manage this disease<\/i>.\u201d said Prof. Azeem Latib<\/b>, Section Head And Director of Interventional Cardiology and Director of Structural Heart Interventions at Montefiore Health System, NYC and Cardiawave Medical Advisory Board Member.<\/b>\n<\/p>\n

\nRegulatory Status<\/b>\n<\/p>\n

\nValvosoft\u00ae is a CE Marked medical device in the EU and is an investigational medical device, not yet approved for commercial use in other countries or areas including the United States.\n<\/p>\n

\nAbout Cardiawave : <\/b>cardiawave.com<\/a>\n<\/p>\n

Contacts<\/b> <\/p>\n

\nCardiawave:<\/b> contact@cardiawave.com<\/a>
Press:<\/b> Annie-Florence Loyer \u2013 aflwoodside@gmail.com<\/a> \u2013 Tel : +33 (0)6 88 20 35 59\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

LEVALLOIS-PERRET, France–(BUSINESS WIRE)–#AorticStenosis–Cardiawave, a pioneering medtech company developing non-invasive ultrasound therapy (NIUT) for aortic stenosis, has received CE Certificate for Valvosoft\u00ae, the world\u2019s first non-invasive therapeutic alternative to treat Severe Symptomatic Aortic Stenosis (sSAS), a serious, degenerative and fast-growing disease due to population aging, which remains without a solution for many patients around the world. … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-62301","6":"format-standard","7":"category-industry"},"yoast_head":"\nVALVOSOFT\u00ae, the First Non-Invasive Treatment for Severe Symptomatic Aortic Stenosis (sSAS) from Cardiawave Receives CE Marking - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/valvosoft-the-first-non-invasive-treatment-for-severe-symptomatic-aortic-stenosis-ssas-from-cardiawave-receives-ce-marking\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"VALVOSOFT\u00ae, the First Non-Invasive Treatment for Severe Symptomatic Aortic Stenosis (sSAS) from Cardiawave Receives CE Marking - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"LEVALLOIS-PERRET, France–(BUSINESS WIRE)–#AorticStenosis–Cardiawave, a pioneering medtech company developing non-invasive ultrasound therapy (NIUT) for aortic stenosis, has received CE Certificate for Valvosoft\u00ae, the world\u2019s first non-invasive therapeutic alternative to treat Severe Symptomatic Aortic Stenosis (sSAS), a serious, degenerative and fast-growing disease due to population aging, which remains without a solution for many patients around the world. ... 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