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Adagio Medical submits FDA PMA application for vCLAS ventricular ablation system

PUBT·05/21/2026 12:02:37
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Adagio Medical submits FDA PMA application for vCLAS ventricular ablation system
  • Adagio Medical submitted a Premarket Approval application to the FDA for its vCLAS ventricular ablation system to treat drug-refractory, recurrent sustained monomorphic ventricular tachycardia.
  • The filing was backed by the FULCRUM-VT pivotal IDE trial in 209 patients, which reported 97.4% acute clinical success.
  • Six-month results included 84.3% freedom from ICD shock, 2.4% major adverse events.


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: 20260521192887) on May 21, 2026, and is solely responsible for the information contained therein.