LAGUNA HILLS, Calif., Sept. 13, 2023 /PRNewswire/ — In a monumental stride towards revolutionizing heart care, Adagio Medical, Inc. has taken the world of cardiac innovation by storm. Pioneers in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), Adagio Medical proudly announces a historic milestone in their quest to reshape the landscape of heart health.
The stage was set at Banner – University Medical Center in Phoenix, AZ, where the visionary Dr. Roderick Tung, MD, conducted the very first procedure in the United States using Adagio’s groundbreaking vCLAS™ catheter system. This remarkable feat marks the initiation of the FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation for Recurring Monomorphic Ventricular Tachycardia) clinical trial, bearing the identifier NCT # NCT05675865.
Dr. Tung, Division Chief of Cardiology and Director of Cardiovascular Clinical Research at the University of Arizona College of Medicine – Phoenix and Banner – University Medical Center Phoenix, heralded this groundbreaking achievement. “Historically, ventricular tachycardia ablations were carried out using RF catheters, but they often fell short in treating the three-dimensional complexities of this condition,” noted Dr. Tung.
“The ULTC’s ability to create deeper lesions, reaching beyond the average thickness of ventricular myocardium solely from the endocardial surface, represents a game-changing advantage. Conducting early feasibility studies in humans is pivotal for assessing safety and clinical efficacy, and we are honored to have the University of Arizona College of Medicine join hands with Adagio in this pioneering endeavor.”
The FULCRUM-VT trial, spanning four prestigious investigational sites, including Banner – University Medical Center, is poised to enroll 20 patients. These centers of excellence include Vanderbilt University Hospital in Nashville, TN, led by Dr. William Stevenson, Mount Sinai Hospital in NY with Dr. Vivek Reddy, and the University of California in San Francisco, where Dr. Edward Gerstenfeld spearheads the charge. The trial’s eligibility criteria encompass patients with both ischemic and non-ischemic heart disease, implanted cardioverter defibrillators, and indications for ventricular ablation due to recurrent symptomatic monomorphic VTs.
Notably, the trial welcomes patients for both de-novo and first repeat ablations, offering a comprehensive clinical pathway for the vast majority of ventricular ablation candidates. Across the Atlantic, the 64-patient CRYOCURE-VT trial, conducted in Europe and Canada to assess the safety and performance of the vCLAS catheter, has successfully completed enrollment. The data garnered from this venture will play a pivotal role in supporting the CE-Mark approval of this groundbreaking device.
Adagio Medical’s President and CEO, Olav Bergheim, expressed boundless optimism about the future. “The commencement of the FULCRUM-VT study signifies the inaugural step towards introducing Adagio’s ULTC platform technology into the U.S. VT ablation market,” Bergheim declared.
“Our initial published data showcasing the procedural characteristics, acute effectiveness, and safety of ULTC ablations have been nothing short of promising. We firmly believe that the amalgamation of CRYOCURE-VT and FULCRUM-VT data will yield a robust, multi-center, global dataset, imperative for the evaluation of this groundbreaking technology.
The VT market is a realm ripe for innovation, and Adagio’s dedicated VT catheter underscores our unwavering commitment to advancing clinical electrophysiology. With this technology, we foresee significant enhancements in procedure effectiveness and long-term outcomes.
This bi-directionally deflectable catheter aligns seamlessly with the same ULTC energy source currently under evaluation as part of the pivotal FDA IDE trial for treating persistent AF (NCT # 04061603). We firmly believe that, once approved by regulatory authorities, vCLAS will become an indispensable technology at every advanced EP ablation program.”
About Banner – University Medical Center Phoenix
Since its inception in 1911, Banner – University Medical Center Phoenix has been an unwavering pillar of medical excellence, extending its healing touch across the vast expanse of Arizona and the Southwest. This venerable institution stands as a cornerstone of Banner – University Medicine, an illustrious academic medical network renowned for its commitment to pioneering healthcare.
With a legacy spanning decades, this teaching hospital has nurtured and shaped thousands of medical luminaries. It proudly serves as the academic medical epicenter for The University of Arizona College of Medicine – Phoenix, fostering the brightest minds in the medical realm.
A beacon of healthcare distinction, this hospital has garnered national acclaim, securing a coveted spot on U.S. News and World Report’s prestigious list of the nation’s finest hospitals. Its expertise spans a diverse spectrum, with specialized prowess in heart care, cancer care, high-risk obstetrics, neurosciences, organ transplants, medical toxicology, and emergency care, boasting the coveted designation of a Level I trauma center.
But that’s not all. Banner – University Medical Center Phoenix is a vital cog in the formidable machinery of Banner Health, a nonprofit healthcare juggernaut spanning six states and comprising 33 hospitals. This is where the future of healthcare unfolds, where innovation meets compassion, and where healing knows no bounds. To dive deeper into this epicenter of medical marvels, visit bannerhealth.com/universityphoenix.
About Adagio Medical
Nestled in the vibrant heart of Laguna Hills, California, lies Adagio Medical, Inc. A dynamic and visionary company with a singular mission: to redefine the landscape of cardiac care through cutting-edge cryoablation technologies. Here, innovation knows no bounds as Adagio pioneers revolutionary treatments, crafting contiguous, transmural lesions that hold the key to combating cardiac arrhythmias.
At Adagio Medical, the horizon of healthcare stretches far and wide, encompassing the treatment of paroxysmal and persistent atrial fibrillation, atrial flutter, and ventricular tachycardia. The pursuit of excellence fuels their relentless efforts to transform lives, one heartbeat at a time.
Notably, Adagio Medical, Inc. stands proudly as a distinguished member of the Fjord Ventures portfolio, a testament to their unwavering commitment to advancing the frontiers of medicine. Join them on this journey towards a healthier heart and a brighter future.