Argá Medtech today announced positive findings from a first-in-human study of its Coherent Sine-Burst Electroporation (CSE) system.
Lausanne, Switzerland-based Argá’s BURST-AF study evaluates the CSE pulsed field ablation (PFA) system. It looks at the treatment of paroxysmal and persistent AFib. It demonstrated 94% overall lesion durability, 100% procedural success and a strong safety profile with a single, stylet-driven, multi-configurable catheter.
Investigators shared findings at the AF Symposium in Boston. Argá also said it reached 50% enrollment in the FDA investigational device exemption (IDE) study. It plans to evaluate the CSE system in up to 360 patients across the U.S. and Europe.
“While pulsed field ablation has transformed AF treatment, many systems report low durability for the complex lesion sets beyond pulmonary vein isolation,” said Dr. Ante Anic, head of the Electrophysiology Lab at KBC Split Hospital and BURST-AF investigator. “In this study, the CSE System enabled efficient, single-catheter ablation across multiple lesion sets with high durability, short ablation times of 20 minutes for pulmonary vein isolation, and an additional 15 minutes for additional linear ablations. These data support sine-burst electroporation as an important next step in AF ablation.”
More about the Argá system
The CSE platform uses a proprietary CSE PFA generator and a multi-configurable catheter. It aims to enable significant flexibility in the treatment of AFib.
Argá designed its sinusoidal/sine wave to allow the tailoring of energy to the different depths of tissue targeted for ablation. CSE’s single, all-in-one catheter delivers the unique waveform through a form factor capable of being shaped to create multiple lesions. Those include circular, linear or focal ablation lesions.
The company says its variability eliminates the need for catheter exchanges. This, in turn, reduces the risk of introducing air bubbles and can reduce procedural time and costs.
While investigational, the CSE PFA system could mark another entrant into the hot PFA market. Current frontrunners on that market include Medtronic, Boston Scientific, Johnson & Johnson MedTech, Abbott and Kardium. The company got a boost with more than $64 million in funding in 2024.
More about the study
BURST-AF enrolled 101 patients with drug-refractory paroxysmal (59%) or persistent (41%) AFib at four clinical sites. Patients underwent cardiac ablation procedures — including pulmonary vein isolation (PVI), posterior wall isolation (PWI) and cavo-tricuspid isthmus (CTI) ablation — with CSE. They received re-mapping procedures at 60-90 days post-ablation and assessments at six and 12 months post-procedure.
Procedural success came in at 100% in both paroxysmal and persistent AFib. Investigators saw PVI durability of 97.4% and 91.7% in those groups, respectively. CTI durability registered at 100% and 97.4% in the respective groups.
At six-month follow-up, 56 of 58 patients (96.6%) of paroxysmal and 35 of 38 (92.1%) of persistent patients were free of AFib, atrial flutter and atrial tachycardia with or without anti-arrhythmic drugs. At 12 months, 50 of 55 (90.9%) of paroxysmal and 28 of 34 (82.4%) of persistent AF patients were free of those conditions.
Safety results demonstrated no pulmonary vein stenosis, silent cerebral events (SCE)/silent cerebral lesions (SCL), clinically apparent coronary spasm, phrenic nerve damage/paralysis, esophageal damage, or conduction disorders.
“These findings validate the clinical and procedural benefits of our CSE system and further increase our confidence that the ongoing U.S. IDE study will achieve its endpoints,” said David Neale, co-founder and CEO at Argá Medtech. “Our ability to reach 50% enrollment in the IDE study in only 4 months underscores the high interest in our unique PFA solution and its potential benefits among the interventional electrophysiology community. We are committed to generating a robust body of data that will support regulatory and an eventual PMA submission for FDA approval of the CSE system.”
