LAGUNA HILLS, Calif., Nov. 28, 2018 /PRNewswire/ — Adagio Medical, Inc., developer of the iCLAS™ technology, the company’s ultra-low temperature intelligent continuous lesion ablation system for the treatment of cardiac arrhythmias, announces updates to its ongoing cryoablation study for Persistent Atrial Fibrillation (PsAF). The study is currently being conducted at two clinical sites in Europe and two additional sites are expected to be added in early 2019.
To date, twenty-five patients have been treated for Persistent and Long-Standing AF. The treatment gives the EP the option to create lesions to isolate the pulmonary veins, the posterior wall of the left atrium and the cavo-tricuspid isthmus. Adagio’s AF cryoablation catheter uses pre-shaped stylets to enable the clinician to adjust the sizes and shapes of the linear lesions to adapt to the patient’s unique cardiac anatomy without requiring multiple catheter exchanges. Temperatures at the freezing element of the catheter reach -190°C with the use of the iCLAS cryoablation console. The ability of the catheters to adapt to a patient’s anatomy combined with the power of the iCLAS console are key to the creation of transmural lesions necessary for the isolation of these critical targets.
In early follow-up data, over 90% of patients remain free of AF at six months following a single procedure. The nine- and twelve-month data show freedom from AF at a rate which represents a significant improvement over the current industry standard.
“The ability of Adagio’s technology to effectively isolate the pulmonary veins and the posterior wall of the left atrium is impressive. Seeing single treatment efficacy that is better than that of other devices with two ablations is indeed a bonus,” says Prof. Lucas Boersma, Principal Investigator at St. Antonius Hospital, Nieuwegein, The Netherlands. “The data so far are extremely encouraging.”
“A dedicated team of engineers and scientists led by our Chief Technical Officer, Alex Babkin, PhD, has developed a cryoablation system capable of transforming how electrophysiologists manage this challenging patient population,” states Hakon Bergheim, Chief Operating Officer, of Adagio Medical. “Our vision is to provide the EP with the ability to create true continuous, transmural lesions anywhere in the heart with a single catheter. The efficacy from the ongoing European trials is very encouraging, and we are looking forward to starting a US study early in 2019.”
About Adagio Medical
Adagio Medical, Inc. (www.adagiomedical.com) is a privately held company located in Laguna Hills, California developing innovative cryoablation technologies that create continuous, linear, transmural lesions to treat cardiac arrhythmias, including paroxysmal and persistent atrial fibrillation, atrial flutter and ventricular tachycardia. Adagio Medical, Inc. is a Fjord Ventures portfolio company. For additional information please send an email to email@example.com.
SOURCE Adagio Medical, Inc.