{"id":62084,"date":"2025-10-24T07:03:06","date_gmt":"2025-10-24T05:03:06","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/"},"modified":"2025-10-24T07:03:06","modified_gmt":"2025-10-24T05:03:06","slug":"protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/","title":{"rendered":"Protaryx Medical Submits 510(k) Application for Its Next-Generation Transseptal Puncture Device"},"content":{"rendered":"<div>\n<p>BALTIMORE&#8211;(BUSINESS WIRE)&#8211;Protaryx Medical, an innovative medical device company developing disruptive access solutions for minimally invasive left-heart procedures, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its proprietary Transseptal Puncture Device.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20251023168876\/en\/2619818\/4\/Protaryx_logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20251023168876\/en\/2619818\/22\/Protaryx_logo.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20251023168876\/en\/2619818\/4\/Protaryx_logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20251023168876\/en\/2619818\/21\/Protaryx_logo.jpg\"><\/a><\/p>\n<p>\nThis submission marks a major milestone in the Company\u2019s mission to redefine safe, efficient and reproducible left-atrium access for structural heart interventions.<\/p>\n<p>\n<b>Key Highlights<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nThe Protaryx Transseptal Puncture Device is designed to provide zero-exchange delivery of left-atrial therapy devices, improving workflow efficiency.<\/li>\n<li>\nThe technology features a highly echogenic, extendable atraumatic positioning probe combined with a standardized RF guidewire compatible with commercially available electrosurgical generators, enabling enhanced visualization, precision and operator ease-of-use.<\/li>\n<li>\nThe Company\u2019s first-in-human (FIH) study, conducted on December 3, 2024, in Asunci\u00f3n, Paraguay (five patients), achieved all procedural success endpoints, no adverse events, substantially reduced fluoroscopic exposure and rapid patient discharge.<\/li>\n<li>\nWith the 510(k) submission, Protaryx is now advancing toward U.S. regulatory clearance and the commercial launch of its device, opening a pathway to broaden access to left-heart therapies and improve patient care.<\/li>\n<\/ul>\n<p>\n<b>Company Commentary<\/b><\/p>\n<p>\n\u201cAchieving 510(k) submission is a pivotal milestone for Protaryx,\u201d said David Mester, Chief Executive Officer of Protaryx. \u201cOur team has worked with laser focus to solve one of the core workflow and ease-of-use challenges in structural heart procedures: transseptal puncture and left-atrial access. This submission brings us one step closer to offering a solution that enables physicians of all experience levels to operate with greater precision, less fluoroscopy, and a faster learning curve.\u201d<\/p>\n<p>\nProtaryx co-founder and System Chief of Cardiac Surgery at Johns Hopkins Health System, Dr. James Gammie added: \u201cThe results from the FIH study show that this device not only meets unmet needs in transseptal access but has the potential to set a new standard for safety, ease-of-use, and efficiency in left-heart interventions.\u201d<\/p>\n<p>\n<b>About Protaryx Medical<\/b><\/p>\n<p>\nProtaryx Medical is a Baltimore-based medical device company committed to developing next-generation transseptal puncture device for structural heart interventions. The Company\u2019s differentiated Transseptal Puncture Device is engineered to streamline left-atrial access with a zero-exchange delivery platform, high-visibility echogenic probe, and RF guidewire compatibility with existing electrosurgical systems.<\/p>\n<p>\nFor more information, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.protaryx.com%2F&amp;esheet=54344409&amp;newsitemid=20251023168876&amp;lan=en-US&amp;anchor=www.Protaryx.com&amp;index=1&amp;md5=d23105397d04d437f62dca3316ca99b3\" rel=\"nofollow\" shape=\"rect\"><b>www.Protaryx.com<\/b><\/a>.<\/p>\n<p>\n<b>Forward-Looking Statements<\/b><\/p>\n<p>\nThis press release contains forward-looking statements that involve risks and uncertainties, including statements regarding Protaryx\u2019s expectations for regulatory clearance by the U.S. Food &amp; Drug Administration, the timing of commercialization, and the potential market impact of the Transseptal Puncture Device. Actual results may differ materially from those projected or implied. Readers are urged to carefully consider the risks, uncertainties and other factors. The Company undertakes no obligation to update forward-looking statements to reflect on subsequent events or circumstances.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Media Contact<\/b><br \/>Protaryx Medical<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#105;lt&#x6f;&#x3a;&#105;&#110;f&#x6f;&#x40;&#112;&#114;o&#x74;&#x61;&#x72;&#121;x&#46;&#x63;&#x6f;&#109;\" rel=\"nofollow\" shape=\"rect\">&#105;&#x6e;&#102;&#x6f;&#64;&#x70;&#114;&#x6f;&#116;&#x61;&#114;&#x79;x&#x2e;c&#x6f;m<\/a><br \/>667.401.6772<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>BALTIMORE&#8211;(BUSINESS WIRE)&#8211;Protaryx Medical, an innovative medical device company developing disruptive access solutions for minimally invasive left-heart procedures, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its proprietary Transseptal Puncture Device. This submission marks a major milestone in the Company\u2019s mission to redefine safe, efficient &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/\">[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-62084","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Protaryx Medical Submits 510(k) Application for Its Next-Generation Transseptal Puncture Device - 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\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Protaryx Medical Submits 510(k) Application for Its Next-Generation Transseptal Puncture Device - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"BALTIMORE&#8211;(BUSINESS WIRE)&#8211;Protaryx Medical, an innovative medical device company developing disruptive access solutions for minimally invasive left-heart procedures, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its proprietary Transseptal Puncture Device. This submission marks a major milestone in the Company\u2019s mission to redefine safe, efficient ... [Read more...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Trend\" \/>\n<meta property=\"article:published_time\" content=\"2025-10-24T05:03:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mms.businesswire.com\/media\/20251023168876\/en\/2619818\/22\/Protaryx_logo.jpg\" \/>\n<meta name=\"author\" content=\"Business Wire\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Business Wire\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\\\/\"},\"author\":{\"name\":\"Business Wire\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/person\\\/02d41342c7a74fa7f0032bb35ef0bb24\"},\"headline\":\"Protaryx Medical Submits 510(k) Application for Its Next-Generation Transseptal Puncture Device\",\"datePublished\":\"2025-10-24T05:03:06+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\\\/\"},\"wordCount\":467,\"publisher\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20251023168876\\\/en\\\/2619818\\\/22\\\/Protaryx_logo.jpg\",\"articleSection\":[\"Industry\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\\\/\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\\\/\",\"name\":\"Protaryx Medical Submits 510(k) Application for Its Next-Generation Transseptal Puncture Device - Pharma Trend\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20251023168876\\\/en\\\/2619818\\\/22\\\/Protaryx_logo.jpg\",\"datePublished\":\"2025-10-24T05:03:06+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/pharma-trend.com\\\/en\\\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\\\/#primaryimage\",\"url\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20251023168876\\\/en\\\/2619818\\\/22\\\/Protaryx_logo.jpg\",\"contentUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20251023168876\\\/en\\\/2619818\\\/22\\\/Protaryx_logo.jpg\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Protaryx Medical Submits 510(k) Application for Its Next-Generation Transseptal Puncture Device\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\",\"name\":\"Pharma Trend\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\",\"name\":\"Pharma Trend\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"\",\"contentUrl\":\"\",\"caption\":\"Pharma Trend\"},\"image\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/person\\\/02d41342c7a74fa7f0032bb35ef0bb24\",\"name\":\"Business Wire\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Protaryx Medical Submits 510(k) Application for Its Next-Generation Transseptal Puncture Device - Pharma Trend","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/","og_locale":"en_US","og_type":"article","og_title":"Protaryx Medical Submits 510(k) Application for Its Next-Generation Transseptal Puncture Device - Pharma Trend","og_description":"BALTIMORE&#8211;(BUSINESS WIRE)&#8211;Protaryx Medical, an innovative medical device company developing disruptive access solutions for minimally invasive left-heart procedures, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its proprietary Transseptal Puncture Device. This submission marks a major milestone in the Company\u2019s mission to redefine safe, efficient ... [Read more...]","og_url":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/","og_site_name":"Pharma Trend","article_published_time":"2025-10-24T05:03:06+00:00","og_image":[{"url":"https:\/\/mms.businesswire.com\/media\/20251023168876\/en\/2619818\/22\/Protaryx_logo.jpg","type":"","width":"","height":""}],"author":"Business Wire","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Business Wire","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/#article","isPartOf":{"@id":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/"},"author":{"name":"Business Wire","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/person\/02d41342c7a74fa7f0032bb35ef0bb24"},"headline":"Protaryx Medical Submits 510(k) Application for Its Next-Generation Transseptal Puncture Device","datePublished":"2025-10-24T05:03:06+00:00","mainEntityOfPage":{"@id":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/"},"wordCount":467,"publisher":{"@id":"https:\/\/pharma-trend.com\/en\/#organization"},"image":{"@id":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/#primaryimage"},"thumbnailUrl":"https:\/\/mms.businesswire.com\/media\/20251023168876\/en\/2619818\/22\/Protaryx_logo.jpg","articleSection":["Industry"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/","url":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/","name":"Protaryx Medical Submits 510(k) Application for Its Next-Generation Transseptal Puncture Device - Pharma Trend","isPartOf":{"@id":"https:\/\/pharma-trend.com\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/#primaryimage"},"image":{"@id":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/#primaryimage"},"thumbnailUrl":"https:\/\/mms.businesswire.com\/media\/20251023168876\/en\/2619818\/22\/Protaryx_logo.jpg","datePublished":"2025-10-24T05:03:06+00:00","breadcrumb":{"@id":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/#primaryimage","url":"https:\/\/mms.businesswire.com\/media\/20251023168876\/en\/2619818\/22\/Protaryx_logo.jpg","contentUrl":"https:\/\/mms.businesswire.com\/media\/20251023168876\/en\/2619818\/22\/Protaryx_logo.jpg"},{"@type":"BreadcrumbList","@id":"https:\/\/pharma-trend.com\/en\/protaryx-medical-submits-510k-application-for-its-next-generation-transseptal-puncture-device\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/pharma-trend.com\/en\/"},{"@type":"ListItem","position":2,"name":"Protaryx Medical Submits 510(k) Application for Its Next-Generation Transseptal Puncture Device"}]},{"@type":"WebSite","@id":"https:\/\/pharma-trend.com\/en\/#website","url":"https:\/\/pharma-trend.com\/en\/","name":"Pharma Trend","description":"","publisher":{"@id":"https:\/\/pharma-trend.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/pharma-trend.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/pharma-trend.com\/en\/#organization","name":"Pharma Trend","url":"https:\/\/pharma-trend.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/logo\/image\/","url":"","contentUrl":"","caption":"Pharma Trend"},"image":{"@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/person\/02d41342c7a74fa7f0032bb35ef0bb24","name":"Business Wire"}]}},"_links":{"self":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts\/62084","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/comments?post=62084"}],"version-history":[{"count":0,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts\/62084\/revisions"}],"wp:attachment":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/media?parent=62084"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/categories?post=62084"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/tags?post=62084"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}