Argá Medtech Initiates Trial to Assess Effectiveness of CSE in Patients with Atrial Fibrillation

Argá Medtech has begun enrollment in their First-in-Human Clinical Trial “Coherent Sine Burst Electroporation (CSE) System Pilot Study in Patients with Atrial Fibrillation (BURST-AF).”
 
The study is designed to test the acute safety and efficiency of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation (AFib). The first five patients, four with paroxysmal and one with persistent AFib, were successfully treated by Dr. Giorgi Papiashvili with support from Dr. Ante Anic, at the Healthycore Medical Center in Tbilisi, Georgia.
 
The CSE system consists of a configurable (circular, linear, and focal) ablation catheter and pulsed field ablation (PFA) generator. In contrast to all other PFA waveforms, CSE employs a unique sinusoidal wave instead of a square wave. CSE is designed to minimize muscle stimulation, decrease bubble formation, and increase targeted energy delivery to create transmural lesions in tissue of any thickness. CSE offers unmatched flexibility to deliver bipolar, unipolar, or a combination of both waveforms that enables the user to titrate the width and depth of the ablation lesion.
 
“We are very pleased with the performance of our CSE System in this initial group of patients,” stated David Neale, CEO of Argá Medtech. “The ability to deliver three different lesion sets with a single catheter, combined with a generator that titrates lesion depth and width, enables electrophysiologists to safely and efficiently treat any location in the heart.”
 
The physicians and lab staff were excited to provide this new therapy option to their AFib patients. “It was easy to change the ablation catheter from circular to linear,” said Dr. Papiashvili, “and not having to exchange catheters for each lesion set is a game changer.”
 
Visiting physician Dr. Ante Anic (University Hospital Split, Croatia) added, “Energy delivery was very impressive, with no muscle stimulation, no bubbles and very adaptable to the patient’s needs. The catheter flexibility allowed the pulmonary veins to be quickly isolated using the circular configuration and then easily changed to deliver a ‘linear single-shot’ roof line.”