The FDA approved clinical trial is aimed at evaluating the company’s ultra-low temperature intelligent continuous lesion ablation system (iCLAS) for persistent atrial fibrillation
Image: Adagio enrols first patient in iCLAS US IDE clinical trial. Photo: Courtesy of fernando zhiminaicela from Pixabay.
US-based medical technology provider Adagio Medical has enrolled the first patient in its iCLAS Investigational Device Exemption (IDE) trial, at the Valley Hospital in Ridgewood, New Jersey, US.
The FDA approved clinical trial is aimed at evaluating the safety and efficacy of the company’s ultra-low temperature intelligent continuous lesion ablation system (iCLAS) for persistent atrial fibrillation (PsAF).
iCLAS trial national principal investigator at the Valley Hospital Suneet Mittal said: “We are pleased to be the first site to enroll a patient in this study.
“This novel cryoablation system offers multiple advantages, including a single catheter to address all ablation needs, irrespective of whether right or left atrium is targeted for ablation, no 3D mapping required, and more comprehensive lesion sets may favorably impact long-term results of ablation in this difficult to treat patient population.”
The study results will be used to support the pre-market application for iCLAS
The trial has been designed to use the One Shot+ Cryoablation Catheter, which makes continuous, transmural lesions and combines ablation and diagnostics in the same catheter, and requires only a single transseptal puncture.
The catheter makes use of an anatomical approach to guide the navigation and prevents the need for electromagnetic mapping, to enable a simplified procedure.
In addition, interchangeable stylets facilitate infinite shapes of both the ablation and diagnostic sections of the catheter, allowing any targeted lesion set.
Adagio develops cryoablation technologies that create continuous, linear, transmural lesions to treat cardiac arrhythmias, including paroxysmal and persistent atrial fibrillation, atrial flutter and ventricular tachycardia.
Adagio CEO Olav Bergheim said: “We are privileged to work with leading electrophysiologists to advance the treatment of atrial fibrillation. Current ablation therapies are used to treat less than 5% of eligible patients due to disappointing clinical outcomes, long procedure times and unsatisfactory profitability for the providers.
“The Adagio procedure aims to transform ablation therapy by addressing each of these challenges, making catheter ablation therapy available to the broader AFib patient population.”