Argá Medtech initiates First-in-Human trial

Atrial fibrillation (AFib) is the most common heart arrhythmia affecting over 33 million patients worldwide and making them 5 times more likely to have a stroke.1 Patients with AFib have a significantly poorer quality of life when compared to healthy individuals, experiencing a variety of symptoms including lethargy, palpitations, dyspnea, chest tightness, sleeping difficulties, and psychosocial distress.

Ablation using thermal energy (radiofrequency or cryogenic) has proven to be an effective treatment in alleviating AFib associated symptoms and improving quality-of-life. However, there are risks associated with the use of thermal energy that include the potential to damage critical structures such as the esophagus or nerves that surround the heart. Pulsed field ablation energy delivery is tissue selective, ablating the selected heart tissue, while sparing nearby tissues.

Argá Medtech is developing the next-generation non-thermal cardiac ablation system. Its unique Pulsed Field Ablation (PFA) power generator offers unmatched flexibility when used with its proprietary catheter. Argá is developing a new PFA platform called Coherent Sine-burst Electroporation (CSE) that offers improved flexibility in titrating lesion depth and securing transmurality of lesions. 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 the 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.

The launched “Coherent Sine Burst Electroporation (CSE) System Pilot 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.

“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.” 

 (Press release/RAN)