Adagio Medical announced the first completed procedure in an FDA IDE study of its VT cryoablation system.
The company picked up FDA investigational device exemption (IDE) for the study of its VT cryoablation system in May. Laguna Hills, California-based Adagio also reported the first commercial procedures in Europe following CE mark approval at that time.
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Adagio built the VT system on its proprietary ultra-low-temperature cryoablation (ULTC) technology. It specifically designed VT to address both safety and effectiveness challenges of VT ablation. It does this by creating large and deep endocardial lesions with minimal attenuation by scar tissue without the need for catheter irrigation.
Dr. William Stevenson (Vanderbilt University Medical Center) and Dr. J. David Burkhardt (Texas Cardiac Arrhythmias Institute) performed the first cases in the FULCRUM-VT trial. Investigators expect to enroll 206 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy. These patients are indicated for catheter ablation of drug refractory ventricular tachycardia (VT) in accordance with current treatment guidelines.
Adagio plans to use study results to obtain FDA premarket approval (PMA) for the VT cryoablation system. It seeks the industry’s broadest indication — purely endocardial ablation of scar-mediated VT.
“We are pleased to partner with the top academic institutions to bring a long-overdue innovation in VT ablation technology to patients in the US,” said Olav Bergheim, president and CEO of Adagio. “Just recently, FULCRUM-VT received Medicare coverage approval from the Center for Medicare and Medicaid Services (CMS) and study approval from Health Canada. We are now focused on accelerating patient enrollment at all study sites.
“The European launch of vCLAS is also accelerating, with a growing number of centers evaluating ULTC technology across the spectrum of VT etiologies and patient presentations.”
