ANNOUNCEMENT: Adagio Medical Announces Initiation and Enrollment of First Patient in PARALELL Trial

-Adagio Medical Announces the Initiation and Enrollment of the First Patient in the PARALELL Trial to Investigate the Safety and Performance of the CryoPulse™ Catheter System for Pulsed Field Ablation and Pulsed Field Cryoablation of Persistent Atrial Fibrillation.

BUSINESS
24 October 2022 Monday 09:49
NewsEditor

ANNOUNCEMENT: Adagio Medical Announces Initiation and Enrollment of First Patient in PARALELL Trial

LAGUNA HILLS, Calif., Oct. 24, 2022/PRNewswire/ -- Adagio Medical, Inc., a leading innovator of catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), announced its first pulsed field cryoablation (PFCA) performed with the Adagio CryoPulse™ catheter system as part of PARALELL (Clinical Trial of Pulsed Field Ablation and Pulsed Field CRyoAbLation in Persistent Atrial Fibrillation), NCT #05408754. The procedure was performed in the St. Antonius Hospital Nieuwegein, The Netherlands, by Lucas Boersma, MD, PhD, professor at Amsterdam UMC and co-principal investigator of the trial.

"PFCA is a single ablation modality consisting of a 30-second ultra-low temperature cryoablation (ULTC) cycle with pulsed field ablation (PFA) delivered at the end of the cycle via a single catheter system," said Dr. Boersma. "The recent ULTC trial established a new benchmark for ablation efficacy in persistent AF with 85% freedom from AF after a single procedure, and the PARALELL trial will test the performance of PFCA against that benchmark." with the added benefit of shorter ablation times. In addition, the trial design allows for randomization of patients to PFCA or PFA, delivered through the same catheter to create identical sets of lesions with similar characteristics."

"PFA has recently captured the attention of the EP community with the expectation of achieving safer and faster procedures based on the selective effect on the myocardium compared to currently dominant point-by-point RF ablations, and several PFA systems are currently clinical evaluation," said Dr. Atul Verma, MD, Associate Professor and Director of the Division of Cardiology at McGill University Health Center, PARALELL Co-Principal Investigator and world-renowned expert on AFP. "Physiologically, PFCA relies on the tissue selectivity of PFA by focusing electric fields on a target myocardial tissue, previously treated with short-duration ULTC to increase lesion depth and ensure transmurality, and by forming the insulating layer of ice between the electrodes and the blood. As a result, the microbubble showers, phrenic nerve entrapment, and muscle contractions seen in traditional PFA are effectively eliminated. So, in effect, we are reaping the benefits of ULTC and PFA collectively, while We minimize their individual disadvantages.

Ablation procedures in the PARALELL trial will be performed using Adagio's first generation PFCA CryoPulse™ catheter in combination with proprietary PFA and iCLAS™ cryoablation consoles. The iCLAS cryoablation system for the treatment of paroxysmal and persistent AF, as well as atrial flutter, has received CE marking and is commercial in Europe. The safety and efficacy of the iCLAS System for the treatment of persistent AF is being evaluated in a US FDA IDE trial (NCT #04061603). Adagio Medical's clinical trial portfolio also includes the Cryocure-VT trial (NCT #04893317) evaluating the safety and performance of the vCLAS™ ULTC Catheter System for the treatment of monomorphic ventricular tachycardias.

"The initiation of the PARALELL trial is another step toward Adagio's goal of advancing the field of clinical PE and improving outcomes for arrhythmia patients with catheter technologies of uncompromising durability, versatility, and safety," said Olav Bergheim, President and CEO of Adagio Medical. "Our immediate goal is to use the results of the PARALELL study to obtain the CE mark for the first generation CryoPulse™ catheter system, thereby making all three ablation modalities, ULTC, PFA and PFCA available to all electrophysiologists, a first in Europe." and finally all over the world".

About Adagio Medical

Adagio Medical, Inc. ( www.adagiomedical.com) is a private company located in Laguna Hills, California, that develops innovative cryoablation technologies that create contiguous transmural lesions to treat cardiac arrhythmias, including paroxysmal and persistent atrial fibrillation, flutter atrial and ventricular tachycardia. Adagio Medical, Inc. is a portfolio company of Fjord Ventures.

Follow Adagio Medical at: