Argá Medtech Reports 94% Lesion Durability and Strong Safety Profile in First-in-Human BURST-AF Trial of Single-Catheter PFA System

Coherent Sine-Burst Electroporation™ Platform demonstrates 100% procedural success and high freedom from AF in paroxysmal and persistent patients

COHERENT-AF U.S. Investigational Device Exemption (IDE) clinical study reaches 50% enrollment

LAUSANNE, Switzerland and SAN DIEGO, Feb. 09, 2026 (GLOBE NEWSWIRE) -- Argá Medtech today announced positive clinical results from the BURST-AF (NCT05572047) first-in-human trial, demonstrating the safety, effectiveness, and durability of its Coherent Sine-Burst Electroporation™ (CSE™) System for the treatment of paroxysmal and persistent atrial fibrillation (AF). Data presented at AF Symposium 2026 (Boston, February 5–7) showed 94% overall lesion durability, 100% procedural success, and an excellent safety profile using a single, stylet-driven, multi-configurable catheter.

AF is the most common heart arrhythmia, affecting about 38 million patients worldwide¹, and it makes them five times more likely to have a stroke than people without AF.²

“While pulsed field ablation has transformed AF treatment, many systems report low durability for the complex lesion sets beyond pulmonary vein isolation,” said Ante Anic, MD, 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.”

Argá Medtech’s CSE™ PFA platform utilizes a proprietary CSE PFA generator and a multi-configurable catheter to enable unmatched flexibility in the treatment of AF. The system’s sinusoidal/sine wave allows energy delivery to be tailored to the different depths of tissue targeted for ablation. The unique waveform is delivered using a single, all-in-one catheter with a form factor that can be shaped to create circular, linear, or focal ablation lesions. This eliminates the need for catheter exchanges, reducing the risk of introducing air bubbles as one catheter is removed and another is reinserted. It can also reduce procedural time and costs.

BURST-AF enrolled 101 patients with drug-refractory paroxysmal (59%) or persistent (41%) AF at four clinical sites. Patients underwent cardiac ablation with the CSE™ System, including pulmonary vein isolation (PVI), posterior wall isolation (PWI), and cavo-tricuspid isthmus (CTI) ablation. Patients were re-mapped at 60-90 days post ablation and also were assessed at 6 and 12 months post procedure. Key study findings include:

• 100% procedural success in both paroxysmal and persistent AF.
• PVI durability of 97.4% and 91.7% in paroxysmal and persistent AF, respectively, at 60-90-day remapping.
• CTI durability of 100% and 97.4% in paroxysmal and persistent AF, respectively, at 60-90-day remapping.
• In patients with persistent AF, inferior and superior PWI durability was 92.1% and 84.2%, respectively.
• At 6-month follow up, 56 of 58 (96.6%) of paroxysmal and 35 of 38 (92.1%) of persistent AF patients were free of AF, atrial flutter (AFL), and atrial tachycardia (AT) with or without anti-arrhythmic drugs (AAD).
• At 12-month follow up:
  • 50 of 55 (90.9%) of paroxysmal and 28 of 34 (82.4%) of persistent AF patients were free of AF, AFL, AT off AAD.
• Safety results show 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 Chief Executive Officer 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.”

COHERENT-AF Study Reaches Enrollment
During the meeting, Argá Medtech also announced that its COHERENT-AF (NCT06784466) IDE clinical trial has reached 50% enrollment. The prospective, non-randomized, trial is designed to evaluate the safety and effectiveness of the CSE™ System in patients with paroxysmal and persistent AF. Up to 360 patients across clinical sites in the United States and Europe will be enrolled.

CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use

About Argá Medtech SA
Argá Medtech SA is developing a Coherent Sine-Burst Electroporation™ (CSE™), Pulsed Field Ablation (PFA) system to treat patients with cardiac arrhythmias. Argá Medtech is setting the standard for the next-generation PFA systems with its versatile catheter design able to create circular, linear, and focal lesions, coupled with a unique CSE™ PFA waveform that allows energy titration based on tissue depth to achieve durable lesions. The company was co-founded in June 2020 by veteran medical device executive David Neale, CEO, and serial entrepreneur Randy Werneth, CTO, and has offices in Lausanne, Switzerland and San Diego, CA, USA. With over 50 years of combined experience in creating and commercializing cardiac and arrhythmia management products, the leadership team is well connected in electrophysiology and understands the current challenges faced by physicians and patients.

To learn more, visit https://argamedtech.com. 

References
1. Lippi, Giuseppe et al. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. International journal of stroke: official journal of the International Stroke Society vol. 16,2 (2021): 217-221. doi:10.1177/1747493019897870. https://pubmed.ncbi.nlm.nih.gov/31955707/
2. World Stroke Organization. Stroke and Atrial Fibrillation. Accessed February 16, 2024. https://www.world-stroke.org/world-stroke-day-campaign/prevent-stroke/stroke-and-atrial-fibrillation

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