First procedure performed in FULCRUM-VT study of ultra-low temperature cryoablation system

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Adagio Medical has announced the first ultra-low temperature cryoablation (ULTC) procedure performed using the Adagio vCLAS catheter system in the USA as part of the FULCRUM-VT clinical trial. The procedure was performed at Banner – University Medical Center (Phoenix, USA) by Roderick Tung.

“The ablations of ventricular tachycardias (VTs) have been historically performed using radiofrequency (RF) catheters and suffer from insufficient lesion depth to deliver a full thickness treatment to a three-dimensional problem,” said Tung. “The ability of ULTC to create lesions deeper than the average thickness of ventricular myocardium exclusively from endocardial surface in pre-clinical models is a major potential advantage. Performing early feasibility studies in humans is critical to testing safety and clinical efficacy and we are proud that University of Arizona College of Medicine has emerged as an early feasibility study site in collaboration with Adagio.”

FULCRUM-VT is set to enrol 20 patients across four investigational sites, including Banner – University Medical Center in Phoenix and three other VT ablation programmes: Vanderbilt University Hospital (Nashville, USA) with William Stevenson, Mount Sinai Hospital (New York, USA) with Vivek Reddy and University of California in San Francisco (San Francsico, USA) with Edward Gerstenfeld.

The enrolment criteria of the trial include both ischaemic and non-ischaemic heart disease, implanted cardioverter defibrillator, and an indication for ventricular ablation due to recurrent symptomatic monomorphic VTs.

Furthermore, the trial will accept the patients for both de novo and a first repeat ablation, thus encompassing the clinical pathway for vast majority of patients undergoing ventricular ablations.

The 64-patient CRYOCURE-VT trial conducted in Europe and Canada to evaluate safety and performance of vCLAS catheter has completed enrolment, and data will be used to support the CE mark approval of the device.

“The initiation of the FULCRUM-VT study is the first step towards bringing Adagio’s ULTC platform technology to VT ablations market in the USA,” said Olav Bergheim, president and CEO of Adagio Medical. “The initial published data on procedural characteristics, acute effectiveness, and safety of ULTC ablations have been encouraging and, we believe, the combination of CRYOCURE-VT and FULCRUM-VT will result in the robust, multicentre, global dataset, essential for the assessment of this ground breaking technology.

“The VT market is largely underserved by industry. Adagio’s dedicated VT catheter is a testimony to our commitment to the advancement of clinical EP and our belief in the future growth of the market based on improved procedure effectiveness and long-term outcomes. The bi-directionally deflectable catheter is compatible with the same ULTC energy source which is currently under evaluation as a part of pivotal FDA IDE trial for the treatment of persistent. We believe that if and once approved by regulatory authorities, vCLAS will be a must-have technology at every advanced EP ablation programme.”


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