Adagio Medical has announced the completion of the first commercial procedures using its recently CE marked ventricular tachycardia (VT) cryoablation system and the US Food and Drug Administration (FDA) approval of the FULCRUM-VT pivotal IDE study of the VT cryoablation system.
The system with the vCLAS cryoablation catheter is based on the company’s proprietary ultra-low cryoablation technology (ULTC) and was designed specifically to address the challenges of VT ablations, with features and performance making it time- and effort-efficient across the range of purely endocardial ablation strategies in patients with multiple VT aetiologies, the company said in a press release.
“Since the recent CE mark approval, we have done a number of Adagio’s ablation procedures on patients with different types of VT and challenging PVCs and our initial experience is very convincing,” said Roland Tilz (University Clinic Schleswig-Holstein, Lübeck, Germany) who performed the first commercial cases. “The size and depth of the lesions achievable using ULTC technology and catheter design makes it a game changer in time consuming large area ablations. It is also a very promising approach for targeting deep mid-myocardial circuits which represent a major challenge for the conventional radiofrequency (RF) ablations.
“If safety and effectiveness of the technology demonstrated in recently published Cryocure-VT study is confirmed in the postmarket setting, that will change the risk-benefit calculation when selecting candidates for the ablation and allow us to treat more patients, earlier in their disease process. And, in our case, to cut the wait time for patients already suffering from debilitating symptoms associated with drug-refractory ventricular tachycardias.”
In the USA, the vCLAS technology is being evaluated in the FULCRUM-VT Early Feasibility (EFS IDE) study, which has completed enrolment, with initial data expected to be presented at the 2024 Heart Rhythm Society meeting (16–19 May, Boston, USA).
These data, in combination with the Cryocure-VT dataset support FDA approval for the conversion of the FULCRUM-VT study to pivotal phase. The expanded, single-arm study will enrol 206 patients with monomorphic VT due to structural heart disease of both ischaemic and non-ischaemic origin at twenty US and Canadian centres, with Roderick Tung (Banner University Medical Center Phoenix, Phoenix, USA) and Atul Verma (McGill University Health Centre, Montreal, Canada) serving as study co-rincipal Investigators.
“Both of us have extensive experience performing VT ablations using ULTC technology in the earlier studies and recognise the value it brings to the procedure,” said Verma. “There is a pent-up demand for innovation in the VT ablation space, so we expect a lot of interest in study participation from the top academic electrophysiology programmes in the USA.”
“We greatly appreciate the partnership from the electrophysiology community in the USA and EU as we expand our proprietary ULTC platform to the benefit of the sizeable, yet underserved population of patients with drug-refractory VTs,” said Olav Bergheim, president and CEO of Adagio. “We believe we have a strong momentum in both commercial launch and clinical trials programme, and look forward to sharing our progress on both fronts.”
