Adagio Medical Completes Enrollment in Pivotal U.S. Clinical Trial for Breakthrough Ultra-Low Temperature Cryoablation System for Ventricular Tachycardia

Reuters10-01

Adagio Medical Completes Enrollment in Pivotal U.S. Clinical Trial for Breakthrough Ultra-Low Temperature Cryoablation System for Ventricular Tachycardia

Adagio Medical Holdings, Inc. has announced the completion of enrollment for the FULCRUM-VT pivotal clinical trial evaluating its vCLAS Cryoablation System for the treatment of monomorphic ventricular tachycardia (MMVT). The U.S. Food and Drug Administration (FDA) has granted the vCLAS System Breakthrough Device Designation, and the device is currently available commercially for MMVT treatment in Europe and select other regions, while its use in the United States remains investigational. The company anticipates completion of the Premarket Approval (PMA) process for the vCLAS System by year-end 2026, consistent with previous guidance. Results from the FULCRUM-VT study have not yet been presented.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Adagio Medical Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251001870474) on October 01, 2025, and is solely responsible for the information contained therein.

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ID: 20251001870474) on October 01, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4082","symbol_name":"医疗保健设备","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251001:nNDL96b8yl:1","article_id":"2572482536","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2572482536","pubTimestamp":1759320100,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Adagio Medical Completes Enrollment in Pivotal U.S. Clinical Trial for Breakthrough Ultra-Low Temperature Cryoablation System for Ventricular Tachycardia. 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The U.S. Food and Drug Administration (FDA) has granted the vCLAS System Breakthrough Device Designation, and the device is currently available commercially for MMVT treatment in Europe and select other regions, while its use in the United States remains investigational. The company anticipates completion of the Premarket Approval (PMA) process for the vCLAS System by year-end 2026, consistent with previous guidance. Results from the FULCRUM-VT study have not yet been presented.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Adagio Medical Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. 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