{"id":61304,"date":"2025-05-22T19:02:20","date_gmt":"2025-05-22T17:02:20","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/cardiawave-announces-positive-12-month-results-from-its-valvosoft-fim-study-and-valvosoft-pivotal-study-for-the-treatment-of-severe-symptomatic-aortic-stenosis-ssas\/"},"modified":"2025-05-22T19:02:20","modified_gmt":"2025-05-22T17:02:20","slug":"cardiawave-announces-positive-12-month-results-from-its-valvosoft-fim-study-and-valvosoft-pivotal-study-for-the-treatment-of-severe-symptomatic-aortic-stenosis-ssas","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/cardiawave-announces-positive-12-month-results-from-its-valvosoft-fim-study-and-valvosoft-pivotal-study-for-the-treatment-of-severe-symptomatic-aortic-stenosis-ssas\/","title":{"rendered":"Cardiawave Announces Positive 12-Month Results from Its \u201cValvosoft\u00ae FIM Study\u201d and &#8220;Valvosoft\u00ae Pivotal Study&#8221; for the Treatment of Severe Symptomatic Aortic Stenosis (sSAS)"},"content":{"rendered":"<div>\n<p class=\"bwalignc\">\n<b>At the EuroPCR 2025 Congress \u2013 Paris<\/b>\n<\/p>\n<p>\n<b><i>Results confirm the promise of non-invasive ultrasound therapy (NIUT) previously observed in earlier clinical studies.<\/i><\/b>\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20250522089892\/en\/2477915\/5\/visuel_cardiawave.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250522089892\/en\/2477915\/22\/visuel_cardiawave.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20250522089892\/en\/2477915\/5\/visuel_cardiawave.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250522089892\/en\/2477915\/21\/visuel_cardiawave.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20250522089892\/en\/2477913\/5\/Cardiawave_Logotype.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250522089892\/en\/2477913\/22\/Cardiawave_Logotype.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20250522089892\/en\/2477913\/5\/Cardiawave_Logotype.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250522089892\/en\/2477913\/21\/Cardiawave_Logotype.jpg\"><\/a><\/p>\n<ul class=\"bwlistdisc\">\n<li>\n<b>91%<\/b> of patients were free of major adverse cardiac events (MACE) at 30 days (achieving the primary endpoint objective MACE \u2264 25%).\n<\/li>\n<li>\n<b>85%<\/b> of patients experienced an improvement or stabilization in their NYHA class.\n<\/li>\n<li>\n<b>An average 9-point improvement <\/b>in the KCCQ (Kansas City Cardiomyopathy Questionnaire) score, indicating a significant gain<b> in quality of life.<\/b>\n<\/li>\n<li>\n<b>A 43% increase in aortic valve area (AVA) <\/b>at 12 months compared to the natural progression of the disease.\n<\/li>\n<\/ul>\n<p>LEVALLOIS-PERRET, France&#8211;(BUSINESS WIRE)&#8211;Cardiawave SA, medtech company specialized in valvular heart disease, presented today at the <b>EuroPCR<\/b> Congress the 12-month results from its &#8220;<b>Valvosoft\u00ae FIM Study<\/b>&#8221; and &#8220;<b>Valvosoft\u00ae Pivotal Study<\/b>&#8221; evaluating its innovative non-invasive ultrasound therapy (<b>NIUT<\/b>) device for the treatment of Severe Symptomatic Aortic Stenosis (<b>sSAS<\/b>).\n<\/p>\n<p>\nFollowing two First-in-Human studies (40 patients) that demonstrated the safety and feasibility of the therapy, and a multicenter, prospective, single-arm pivotal study (60 patients), conducted in total on 100 elderly patients with multiple comorbidities treated across 12 European centers in 4 countries, <b>the treatment has shown feasibility, safety, and efficacy<\/b>. <b>Durable clinical benefits<\/b> were observed one year after treatment, including improved cardiac function and significantly enhanced patient quality of life.\n<\/p>\n<p>\n\u201c<i>These positive 12-month results confirm the ability of this innovative technology to significantly improve hemodynamics and patient quality of life in a completely non-invasive way. This device is emerging as a serious long-term therapeutic option for aortic stenosis. These results also open the door to additional indications, such as pre-TAVI preparation<\/i>,\u201d said <b>Professor H\u00e9l\u00e8ne Eltchaninoff, Head of the Cardiology Department at Rouen University Hospital <\/b>and principal investigator of the study, during <b>her presentation at the EuroPCR Congress in Paris on May 22.<\/b>\n<\/p>\n<p>\n<b>A New Option for Patients Without Therapeutic Alternatives<\/b>\n<\/p>\n<p>\nIn 2024, approximately 2.5 million people over the age of 75 suffer from sSAS in the EU and the USA<sup>1 <\/sup>. This therapy could become <b>the first non-invasive therapeutic alternative<\/b> to treat sSAS\u2014a serious, degenerative, and fast-growing disease due to population aging\u2014which remains without a solution for many patients.\n<\/p>\n<p>\n\u201c<i>These results are very encouraging. They reinforce our determination to make this non-invasive therapy accessible to as many people as possible, including for complementary indications such as pre-TAVI preparation<\/i>,\u201d said <b>Cardiawave\u2019s leadership team<\/b>. \u201c<i>We are excited to move forward with regulatory steps in Europe and the United States, aiming for a European market launch next year<\/i>.\u201d\n<\/p>\n<p>\nValvosoft\u00ae is an investigational medical device and is not yet approved for commercial use in the European Union or the United States.\n<\/p>\n<p>\n<b>About Cardiawave : <\/b><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.cardiawave.com&amp;esheet=54259198&amp;newsitemid=20250522089892&amp;lan=en-US&amp;anchor=www.cardiawave.com&amp;index=1&amp;md5=1235b3a340ec08ce8bd3c7b67e4757ca\" rel=\"nofollow\" shape=\"rect\"><b>www.cardiawave.com<\/b><\/a>\n<\/p>\n<p>\n<sup>1<\/sup> Durko AP, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. European Heart Journal. July 01, 2018; 39(28):2635-2642. (DOI: 10.1093\/eurheartj\/ehy107)\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Cardiawave:<\/b><br \/><a target=\"_blank\" href=\"mailto:conta&#99;&#116;&#64;&#99;&#97;&#114;&#100;&#105;&#97;&#119;&#97;&#118;&#101;&#46;&#99;&#x6f;&#x6d;\" rel=\"nofollow\" shape=\"rect\">&#x63;&#111;&#110;t&#x61;&#x63;&#116;&#64;&#x63;&#x61;&#114;di&#x61;&#119;&#97;v&#x65;&#x2e;&#99;o&#x6d;<\/a>\n<\/p>\n<p>\n<b>Press:<\/b><br \/>Emilie D\u00e8bes Agence Yucatan \u2013 <a target=\"_blank\" href=\"&#x6d;a&#x69;&#108;t&#x6f;&#58;&#x65;&#100;e&#x62;&#101;&#x73;&#64;y&#x75;&#99;&#x61;&#x74;a&#x6e;&#46;f&#x72;\" rel=\"nofollow\" shape=\"rect\">&#x65;&#100;e&#x62;&#x65;&#115;&#64;&#x79;&#x75;&#99;a&#x74;&#x61;&#110;&#46;&#x66;&#x72;<\/a> \u2013 T\u00e9l : 00-33-669-39-34-84\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>At the EuroPCR 2025 Congress \u2013 Paris Results confirm the promise of non-invasive ultrasound therapy (NIUT) previously observed in earlier clinical studies. 91% of patients were free of major adverse cardiac events (MACE) at 30 days (achieving the primary endpoint objective MACE \u2264 25%). 85% of patients experienced an improvement or stabilization in their NYHA &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/cardiawave-announces-positive-12-month-results-from-its-valvosoft-fim-study-and-valvosoft-pivotal-study-for-the-treatment-of-severe-symptomatic-aortic-stenosis-ssas\/\">[Read more&#8230;]<\/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-61304","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Cardiawave Announces Positive 12-Month Results from Its \u201cValvosoft\u00ae FIM Study\u201d and &quot;Valvosoft\u00ae Pivotal Study&quot; for the Treatment of Severe Symptomatic Aortic Stenosis (sSAS) - 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\/cardiawave-announces-positive-12-month-results-from-its-valvosoft-fim-study-and-valvosoft-pivotal-study-for-the-treatment-of-severe-symptomatic-aortic-stenosis-ssas\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cardiawave Announces Positive 12-Month Results from Its \u201cValvosoft\u00ae FIM Study\u201d and &quot;Valvosoft\u00ae Pivotal Study&quot; for the Treatment of Severe Symptomatic Aortic Stenosis (sSAS) - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"At the EuroPCR 2025 Congress \u2013 Paris Results confirm the promise of non-invasive ultrasound therapy (NIUT) previously observed in earlier clinical studies. 91% of patients were free of major adverse cardiac events (MACE) at 30 days (achieving the primary endpoint objective MACE \u2264 25%). 85% of patients experienced an improvement or stabilization in their NYHA ... 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