Adagio Medical has announced the completion of the first procedures in the FULCRUM-VT US Food and Drug Administration (FDA) pivotal investigational device exemption (IDE) study of the company’s ventricular tachycardia (VT) cryoablation system. The procedures were performed by William Stevenson at Vanderbilt University Medical Center (Nashville, USA) and J David Burkhardt at Texas Cardiac Arrhythmias Institute (TCAI; Austin, USA).
FULCRUM-VT is a prospective, multicentre, open-label, single-arm study enrolling 206 patients with structural heart disease of both ischaemic and non-ischaemic cardiomyopathy, indicated for catheter ablation of drug-refractory VT in accordance with current treatment guidelines.
The results of the study will be used to obtain US FDA premarket approval (PMA) for Adagio’s VT cryoablation system with the vCLAS cryoablation catheter, which—as stated in a company press release—boasts the industry’s broadest indication for purely endocardial ablation of scar-mediated VT.
“Our centre enrolled six patients in the early feasibility stage of [the] FULCRUM-VT programme, with encouraging results,” said Stevenson. “Today’s procedures mark the expansion of the programme to 20 centres in the USA and Canada, allowing for the robust evaluation of Adagio’s technology in a large and challenging population of patients with structural heart disease. The only approved ablation option we can currently offer these patients is based on radiofrequency [RF] energy, which has well-known limitations for ablations in thicker cardiac tissue and when managing patients at risk of cardiac decompensation—the limitations this system may help overcome.”
“This was TCAI’s first experience with Adagio’s system,” Burkhardt added, “and we successfully and safely ablated a non-ischaemic scar in tissue with depth exceeding 10mm in the proximity of the artificial transcatheter aortic valve, which limited the achievable depth of other available technologies. This gives us confidence and motivation as we continue with study enrolment.”
The Adagio Medical VT cryoablation system with the vCLAS cryoablation catheter is based on the company’s proprietary ultra-low temperature cryoablation (ULTC) technology, and was designed specifically to address both safety- and effectiveness-related challenges of VT ablation by creating large and deep endocardial lesions with minimal attenuation by scar tissue without the need for catheter irrigation—a known risk for acute heart failure in patients undergoing RF ablations.
The system recently gained CE-mark approval and is commercially available in select European countries, according to Adagio.
“We are pleased to partner with the top academic institutions to bring a long-overdue innovation in VT ablation technology to patients in the USA,” said Olav Bergheim, president and chief executive officer of Adagio. “Just recently, FULCRUM-VT received Medicare coverage approval from the Centers for Medicare and Medicaid Services (CMS) and study approval from Health Canada. We are now focused on accelerating patient enrolment at all study sites. The European launch of vCLAS is also accelerating, with a growing number of centres evaluating ULTC technology across the spectrum of VT aetiologies and patient presentations.”
