Adagio Medical Announces Completion of First Procedures in FULCRUM-VT U.S. FDA Pivotal IDE of Ventricular Tachycardia Cryoablation System
Adagio Medical Holdings, Inc (ADGM)
Company Research
Source: Business Wire
LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Adagio Medical Holdings, Inc. (Nasdaq: ADGM; “Adagio Medical”, “Adagio” or the “Company”), a leading innovator in catheter ablation technologies, today announced the completion of the first procedures in FULCRUM-VT U.S. Food and Drug Administration (FDA) Pivotal IDE study of Adagio’s VT Cryoablation System. Procedures were performed by Professor William G. Stevenson, MD, at Vanderbilt University Medical Center in Nashville, TN and Dr. J. David Burkhardt at Texas Cardiac Arrhythmias Institute (TCAI) at Austin, TX.FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia, NCT05675865) is a prospective, multi-center, open-label, single-arm study, enrolling 206 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory ventricular tachycardia (VT) in accordance with current treatment guidelines. The results of the
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