Adagio Medical Holdings, Inc. (Nasdaq: ADGM) has announced the successful completion of initial procedures in the FULCRUM-VT study, a pivotal trial approved by the U.S. Food and Drug Administration (FDA) for its VT Cryoablation System.

The procedures took place at Vanderbilt University Medical Center in Nashville, TN, and the Texas Cardiac Arrhythmias Institute (TCAI) in Austin, TX.

The FULCRUM-VT study, which stands for Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia (NCT05675865), is a prospective, multi-centre, open-label, single-arm trial.

It aims to enrol 206 patients with structural heart disease, including both ischemic and non-ischemic cardiomyopathy, who have drug-resistant ventricular tachycardia (VT). The results will be used to seek FDA premarket approval for Adagio’s VT Cryoablation System, featuring the vCLAS™ cryoablation catheter, which is designed for endocardial ablation of scar-mediated VT.

The study has expanded to include 20 centres across the US and Canada, allowing for comprehensive evaluation of Adagio’s technology in a significant patient population.

Currently, the only available ablation method for these patients uses radiofrequency (RF) energy, which has limitations when dealing with thicker cardiac tissues and patients at risk of heart failure. Adagio’s system aims to overcome these challenges.

At TCAI, the team successfully ablated a non-ischemic scar in tissue that exceeded 10 mm in depth, which previous technologies struggled to address, particularly near an artificial transcatheter aortic valve.

The VT Cryoablation System utilises Adagio’s proprietary ultra-low temperature cryoablation technology (ULTC), specifically designed to tackle the safety and effectiveness issues associated with VT ablation.

It creates large, deep endocardial lesions without the need for catheter irrigation, reducing the risk of acute heart failure often associated with RF ablations. The system has recently received CE-Mark approval and is now available in select European countries.

Adagio Medical is collaborating with leading academic institutions to advance this innovative VT ablation technology in the US. The FULCRUM-VT study has received Medicare coverage approval from the Centers for Medicare and Medicaid Services (CMS) and approval from Health Canada, with a focus on accelerating patient enrolment across all study sites.

The launch of the vCLAS catheter in Europe is also progressing, with an increasing number of centres exploring ULTC technology for various VT conditions.
 

 

Source: adagiomedical.com

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