– Second generation pulsed field ablation system will be evaluated in paroxysmal and persistent atrial fibrillation patients to gain FDA approval –
LAUSANNE, Switzerland and SAN DIEGO, Sept. 18, 2025 /PRNewswire/ — Argá Medtech, developers of the Coherent Sine-Burst Electroporation™ (CSE™) System, a next-generation pulsed field ablation (PFA) system for treating cardiac arrhythmias, including atrial fibrillation (AF), announced today initial enrollments in the COHERENT-AF clinical trial. COHERENT-AF, a U. S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial is a prospective, non-randomized, trial designed to evaluate the safety and effectiveness of the CSE System in patients with paroxysmal and persistent atrial fibrillation (AF). The COHERENT-AF trial will enroll up to 360 patients across clinical sites in the United States and Europe.
The first patients were treated by Dr. Ante Anic, at KBC Split Hospital, Split, Croatia. Post-procedure all patients were doing well and have subsequently been released from hospital to continue their recovery. Following the procedures Dr. Anic noted that “The flexibility of the CSE platform fills a gap when treating patients beyond pulmonary vein isolation. The single, stylet-driven, multi-configurable ablation catheter easily transitions to deliver linear and focal ablations providing procedural efficiencies when treating both paroxysmal and persistent AF patients and adds an additional layer of safety by eliminating catheter exchanges.”
The CSE system has been used to date in over 100 patients demonstrating greater than 94% lesion durability at 3 months, 92.6% freedom from atrial arrhythmias at 6-months and a 1.0% adverse event rate in Arga Medtech’s initial BURST-AF clinical study.1 “Initiation of COHERENT-AF is a major milestone for Arga Medtech,” said David Neale, CEO of Argá Medtech. “It marks the start of our journey to bring a next generation, safe, fast, and effective ablation treatment to the millions of people affected by cardiac rhythm disorders and atrial fibrillation.”
The company’s CSE™ PFA platform – with its proprietary CSE™ PFA generator and a multi-configurable catheter – brings unmatched flexibility to the treatment of AF. It offers several advantages over other PFA platforms, which are typically powered by square wave energy sources. Argá Medtech’s CSE™ system uses a sinusoidal/sine wave, allowing physicians to configure the energy delivery to achieve a transmural lesion for different depths of the tissue to be ablated. The waveform is delivered through a versatile, all-in-one catheter that can be shaped to create circular, linear, or focal ablation lesions, eliminating the need to perform catheter exchanges to achieve the desired treatment strategy. This simplifies the procedure, reduces the risk of introducing air bubbles as one catheter is removed and another is reinserted, and reduces costs.
AF is the most common heart arrhythmia, affecting about 38 million patients worldwide2, and it makes them five times more likely to have a stroke.3 While ablation using thermal energy has proven to be an effective treatment in alleviating AF symptoms, there are risks associated with using thermal energy.4 PFA energy delivery is tissue-selective, ablating the intended heart tissue, while sparing nearby tissues and avoiding thermal injury, e.g. to the esophagus or the phrenic nerve.
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:
Anic, Ante et al. Sine-wave electroporation in patients with atrial fibrillation – Initial results of the BURST-AF study. Heart Rhythm (2025) https://doi.org/10.1016/j.hrthm.2025.04.042
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/
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
Aldaas OM, Malladi C, Aldaas AM, Han FT, Hoffmayer KS, Krummen D, Ho G, Raissi F, Birgersdotter-Green U, Feld GK, Hsu JC. Safety and acute efficacy of catheter ablation for atrial fibrillation with pulsed field ablation vs thermal energy ablation: A meta-analysis of single proportions. Heart Rhythm O2. 2023 Sep 12;4(10):599-608. doi: 10.1016/j.hroo.2023.09.003. PMID: 37936671; PMCID: PMC10626185. https://pubmed.ncbi.nlm.nih.gov/37936671/
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SOURCE Arga Medtech