Adagio Medical has reported preliminary acute efficacy and safety findings from its FULCRUM-VT Study, assessing the use of Ultralow Temperature Cryoablation (ULTC) for treating sustained monomorphic ventricular tachycardia (SMVT) in individuals with ischemic and nonischemic cardiomyopathy (ICM/NICM).
The multi-centre, prospective, single-arm, open-label study is designed to assess the safety and efficacy of ULTC in patients with scar-related VT that is unresponsive to antiarrhythmic medications, with a focus on those with a left ventricular ejection fraction (LVEF) over 20%.
It involved 207 subjects across 19 sites in Canada and the US, who underwent VT ablation using the company’s ULTC system.
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The patient cohort included individuals with ICM and NICM, with a LVEF of 35+/-10%.
The study reported a mean procedure time of 206+/-68 minutes.
Notably, the acute clinical success rate was 97.4%, with non-inducibility of target ventricular arrhythmias achieved, and 96.7% of subjects had all clinically relevant VTs eliminated as determined by post-ablation programmed electrical stimulation.
In terms of safety, the study observed a 2.5% incidence of major adverse events. This included four peri-procedural mortalities, with one case being directly attributed to the investigational device as determined by an independent clinical events committee.
The company noted that further reports on long-term results and the effectiveness of the treatment on different myocardial substrates are expected in the future.
The findings from this study will inform Adagio’s application for Food and Drug Administration premarket approval for its vCLAS Cryoablation System.
This could potentially result in the wider industry indication for purely endocardial ablation of scar-mediated VT, the company added.
While the vCLAS Cryoablation System is already available in Europe and other regions to treat MVT, its use in the US is currently for investigational purposes only.
Adagio Medical CEO Todd Usen said: “We are pleased with the preliminary FULCRUM-VT acute data, which highlight the potential of Adagio’s proprietary ULTC technology to transform treatment for patients with ventricular tachycardia.
“On behalf of the entire Adagio Medical team, I want to thank all of the investigators, research coordinators and patients who have supported this study and whose commitment to serving this underserved population of patients will bring us one step closer to a purpose-built solution for VT.”
In December 2024, the company announced the appointment of Usen as the company’s new CEO and director, and Orly Mishan as the Board of Directors’ chairperson.
