Adagio Medical has reported positive six-month data from its pivotal FULCRUM-VT trial, supporting its plans to seek premarket approval from the US Food and Drug Administration (FDA) for the vCLAS ventricular ablation system.
The open-label, multi-centre, prospective, single-arm investigational device exemption trial demonstrated 98% non-inducibility of targeted ventricular tachycardias (VT) at the end of the procedure.
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It also reported a 2.4% rate of protocol-defined major adverse events, indicating a promising safety profile.
Additionally, 84% of participants remained free from implantable cardioverter defibrillator shock at the six-month mark while 59% experienced no recurrence of VT during the same period.
There were equivalent results for patients with both ischaemic and non-ischaemic cardiomyopathy, with more than 80% fewer patients experiencing implantable cardioverter defibrillator (ICD) shock six months after ablation compared to before the procedure.
Furthermore, 72% of patients either reduced or discontinued their use of amiodarone by six months. The study noted a low 1.9% 30-day rate of VT-related hospital readmission.
The trial is evaluating the vCLAS cryoablation system at 20 centres across Canada and the US.
It included 209 patients with structural heart disease who were indicated for catheter ablation of drug-refractory VT, according to current clinical guidelines.
FUCLUM-VT stands as the first fully enrolled IDE clinical trial for VT to incorporate both ischaemic and non-ischaemic cardiomyopathy patients.
Adagio Medical CEO Todd Usen said: “These pivotal results represent a noteworthy milestone for Adagio and validate the potential for our ULTA [ultra-low temperature ablation] technology to address a significant unmet need for treating one of the most complex and challenging arrhythmias.”
Further results indicated a mean ablation time of 54 minutes per patient with 11.5 average lesions.
Major adverse events occurred in 2.4%, including four peri-procedural deaths, with two possibly related to the device.
In October 2025, Adagio Medical secured a $19m upfront payment through a private placement, aimed at advancing its ultra-low temperature cryoablation (ULTC) technology for VT treatment.
