Adagio Medical Receives IDE Approval from the FDA to Investigate Next-Generation vCLAS® Ventricular Ablation System
Adagio Medical Holdings, Inc (ADGM)
Company Research
Source: Business Wire
Designed to Deliver Faster, More Efficient Ablation with Improved Usability on Established, Titratable, Endocardial-Approach ULTA Platform LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to expand the Company’s FULCRUM-VT trial to evaluate the safety and effectiveness of the Company’s next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT).“Ventricular tachycardia remains one of the most difficult arrhythmias to treat, with current ablation approaches often limited by difficulty achieving sufficient lesion depth,” said Dr. William Stevenson, M.D., Professor of Medicine, Principal Site Investigator
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News
- Adagio Medical to Participate in the 25th Annual Needham Virtual ConferenceBusiness Wire
- Adagio Medical Ultralow Temperature Ablation U.S. Pivotal Study Results to be Presented in Late-Breaking Session at Heart Rhythm Society 2026Business Wire
- Adagio Medical Reports Fourth Quarter and Full Year 2025 ResultsBusiness Wire
- Adagio Medical Announces Publication of Pre-Clinical Results for Next Generation Ventricular Ablation CatheterBusiness Wire
- Adagio Medical Highlights Recent Successful Expanded Access Cases with vCLAS™ System, Including Patients with Premature Ventricular Contractions (PVC)Business Wire
ADGM
Sec Filings
- 3/9/26 - Form 4
- 3/9/26 - Form 4
- ADGM's page on the SEC website