Description: smart clinical trial solutions
Below, we are re-publishing with permission the press-release issued by Argá Medtech on Octobe 26, 202 2
EPALINGES, Switzerland, Oct. 26, 2022 (GLOBE NEWSWIRE) — Argá Medtech announced today that it 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 tr
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 ena