Argá Medtech SA

We are starting our FDA IDE! Argá Medtech is pleased to announce that the FDA has granted approval to begin the COHERENT AF IDE trial to test the safety and effectiveness of the Coherent Sine Burst Electroporation™ System (CSE) in patients with paroxysmal and persistent atrial fibrillation.  We anticipate enrollments to begin shortly in selected centers across the US and EU. The CSE System features a single, multi-configurable ablation catheter and sine wave-based pulse field ablation generator.  The catheter uses purpose-built stylets to change its shape allowing the creation of circular, linear and focal ablation lesions anywhere in the atrium, reducing the need for multiple catheters and catheter exchanges during an ablation procedure. The ablation generator delivers controlled bursts of pulsed field ablation using sine waves instead of the more commonly used monophasic or biphasic square wave enabling the ability to titrate lesions to tissue thickness and patient needs. To learn more about Argá Medtech and the CSE Ablation System visit our website at argamedtech.com  #epeeps #atrialfibrillation #electrophysiology #pulsedfieldablation David Neale Randy Werneth Steven McQuillan HTGF | High-Tech Gründerfonds Earlybird Venture Capital MedFocus Gilde Healthcare Advent Life Sciences @LSI

Congratulations to Ante Anic and the KBC Split team for a fantastic live case presentation using Argá Medtech's Coherent Sine Burst Electroporation (CSE) System earlier this week at the Prague Rhythm 2025 Symposium. The Argá system features sine wave-based pulsed field ablation and a single, 8-electrode, stylet-configurable catheter that allows energy to be delivered in a circular, linear or focal configuration. Case highlights included: - PVI in less than 20 minutes using the circular configuration - Isolation of the posterior wall with two linear PFA applications - CTI bidirectional block - Single linear application #electrophysiology #atrialfibrillation #EPeeps #argamedtech #pfa CAUTION – This product is limited by U.S. Federal Law to investigational use. Product is not approved globally and may not be available in your market.

Árga Medtech's Coherent Sine Burst Electroporation  Versatile. Efficient. Safe. Backed by published results from BURST-AF. #argamedtech #electrophysiology #atrialfibrillation Ante Anic Vedran Velagic Giorgi Papiashvili CAUTION – This product is limited by U.S. Federal Law to investigational use. Product is not approved globally and may not be available in your market.

Results from the BURST-AF clinical trial of #ArgaMedtech's Coherent Sine Burst pulsed field ablation system were presented today at #HRS2025 by principal investigator Ante Anic and simultaneously published online in Heart Rhythm Journal Highlights from the study included 90 patients enrolled with both paroxysmal and persistent AF. Remapping was performed at 60 - 120 days post-procedure in 88 patients.  Key points: - Single catheter solution (Stylet-configurable, circular, linear and focal ablation) utilizing Sine Wave Pulsed Field Ablation for paroxysmal and persistent atrial fibrillation. - Lesion durability at 3 months is >98% when using optimized energy delivery and workflow recommendations. - Outcome data at 6- months is promising, with 94.7% (PAF) and 90% (PersistentAF) patients free from recurrent atrial arrhythmias with or without anti-arrhythmic drug therapy. Atrial Fibrillation (AFib) affects over 50 million patients worldwide. Characterized by the irregular firing of the upper chambers of the heart, patients with AFib are at higher risk for stroke and development of heart failure. Patients with AFib experience a variety of symptoms including palpitations, fatigue, shortness of breath and dizziness. Cardiac ablation has become a first-line therapeutic option for select AFib patients. CAUTION – This product is limited by U.S. Federal Law to investigational use. Product is not approved globally and may not be available in your market. #PFA #AtrialFibrillation #PVI #Electrophysiology #KBCSplit #hrs David Neale Randy WernethSteven McQuillan Melvin Lorenzo Download the full manuscript at https://lnkd.in/gEK9ap2H

Earlier today at #HRS2025, Dr. Ante Anic performed a live case during the PFA Summit feature #Arga Medtech 's Coherent Sine Burst Electroporation (CSE) System. The system features pulsed field energy generated with sine waves and a versatile, 7F, stylet-configurable catheter that produces circular, linear, and focal ablation lesions. During the procedure, Dr. Anic safely and efficiently - Isolated the PVs in under 15 minutes using the circular configuration - Created superior and inferior lines to block the posterior wall in under 2 minutes using the linear and focal configurations - Completed a CTI line without incident Interim clinical results from the BURST-AF tiral will be presented Saturday April 26 at 4:06PM during the Late-Breaking Clinical Trials session. CAUTION – This product is limited by U.S. Federal Law to investigational use. Product is not approved globally and may not be available in your market. #PFA #AtrialFibrillation #PVI #Electrophysiology #KBCSplit

🚨 Exciting updates from the 2025 Stanford Biodesign New Arrhythmias Technology Retreat! 🚨 Dr. Melvin Lorenzo presented preclinical findings on the Coherent Sine-Burst Electroporation (CSE) Ablation System, showcasing its versatility and precision in creating durable lesions across multiple atrial targets—all without the need for catheter exchange. 🔬 Key Highlights from the 28-Day Chronic Survival Swine Study: ✅ 100% durable isolation at Day 27-28 with the recommended “Nominal Dose” using the circular catheter configuration ✅ 100% conduction block in linear and point-by-point lesions across the atrial posterior wall in all study animals using the linear catheter configuration ✅ No PV stenosis, phrenic nerve injury, damage to coronary arteries, esophageal damage, or clinically significant hemolysis observed ✅ Significantly lower microbubbles compared to RF ablation in an ECL model and no visible microbubble production via ICE 💡 What sets this system apart? A stylet-driven 7F catheter that transitions seamlessly between circular, linear, and focal configurations—no catheter exchange required. Precision meets flexibility! This innovative approach is poised to redefine safety and performance in atrial fibrillation ablation. 🫀 Ventricular CSE Focal Ablation (Acute Non-Survival In Vivo Study): ✅ Performed endocardially in healthy swine, CSE focal ablation demonstrated effective energy delivery in both unipolar and bipolar modes, confirming its broader utility beyond the atrial ablation (lesion depths >12mm). #StanfordBiodesign #ArgaMedtech #CSEablation #vtinnovation #Electrophysiology #InnovationInAFAblation #AFib #PFA #EPeeps

At #EHRA2025, pre-clinical research was presented by Dr Konstantinos Vlachos on the Coherent Sine-Burst Electroporation (CSE) ablation system in a chronic porcine beating heart model. The study evaluated the safety and efficacy of this novel technology for pulmonary vein isolation (PVI) and linear lesions in the atria. 🔬 Key Findings: ✅ 96% of pulmonary veins successfully isolated at 28 days post-ablation. ✅ 93% of linear lesions demonstrated conduction block and transmurality. ✅ No PV stenosis, nerve injury, or damage to coronary arteries or esophagus. These results highlight the potential of CSE ablation as a safe and effective approach for cardiac ablation, offering precise lesion formation without catheter exchange. The flexibility of the platform with its configurable catheter. #ArgaMedtech #BURSTAF #Electrophysiology #AFib #EHRA2025 #InnovationInAFAblation #EPeeps Annelies Vanderper Randy Werneth David Neale Steven McQuillan

At the *EHRA2025 Congress in Vienna, Dr. Ivan Sikiric showcased a moderated poster detailing an innovative approach to persistent atrial fibrillation (AF) ablation using the Coherent Sine-Burst (CSE) Ablation System in the BURST-AF study. This case highlights advancements in procedural efficiency and patient outcomes through flexible, all-purpose, pulsed-field ablation (PFA) platform. 🔹 Key Case Highlights: ✅ Pulmonary vein isolation (PVI) was successfully performed using the CSE Circular Ablation Catheter configuration. ✅ During the LA posterior superior line ablation with the CSEAblation Catheter in linear configuration, AF converted to typical atrial flutter, a crucial step in rhythm control. ✅ Typical flutter was then converted to sinus rhythm with a single application on the Cavotricuspid Isthmus. This case underscores the importance of versatile pulsed-field ablation (PFA) platforms and specialized ablation tools in optimizing the efficiency of complex procedures and improving patient outcomes. With continued innovation in AF ablation, we move closer to safer, more effective, and personalized treatments. hashtag #ArgaMedtech hashtag #BURSTAF hashtag #Electrophysiology hashtag #AFib hashtag #EHRA2025 hashtag #InnovationInAFAblation hashtag #KBCSplit hashtag #EPeeps Ante Anic Annelies Vanderper Randy Werneth Steven McQuillan David Neale i Ante Anic, Ivan Sikirik, Annelies Vanderper, David Neale, Randy Werneth Steven McQuillan

We are thrilled to announce the kickoff to an exciting conference season for Argá Medtech!   Argá will be showcasing our groundbreaking Coherent Sine-Burst Electroporation (CSE) system and sharing the latest results from our BURST-AF study at three major events: European Heart Rhythm Association (EHRA) Prague Rhythm Heart Rhythm Society (HRS)   Don't miss this opportunity to: ✅ Discover more about our innovative CSE technology ✅ Learn the extent of our preclinical studies and broad clinical experience ✅ See our technology in action during two live case transmissions Our team is eager to connect with fellow professionals and share how CSE is revolutionizing cardiac ablation for atrial fibrillation. Join us as we continue to push the boundaries of arrhythmia management. See you at the conferences starting this weekend in Vienna for EHRA!   #EHRA #HRS #PragueRhythm #CardiacAblation #AtrialFibrillation #MedTech #Innovatio #epeeps David Neale Steven McQuillan Randy Werneth

Today Dr Ante Anic from KBC Split presented during the Spotlight Session promising first-in-human preliminary results of BURST-AF. In total, 78 subjects were enrolled across 3 European sites.  All lesion sets were completed using the Coherent Sine-Burst Electroporation™ (CSE™) generator and CSE ablation catheter in either the circular, linear and/or focal configuration. Safety assessments included a brain MRI sub-study, microbubble observation during PFA application, PV stenosis, and esophageal injury. Seventy-seven of 78 subjects have undergone remapping at ~90 days. Dr. Anic shared preliminary study results demonstrating an excellent safety profile combined with a high acute procedural efficacy and chronic durability at 90-days. BURST-AF is a first in human study to evaluate the Coherent Sine-Burst Electroporation (CSE) Ablation system as a novel PFA platform. The study was designed as a prospective, single-arm, multi-center, non-randomized study to assess the safety, efficiency and effectiveness of the CSE ablation system. The CSE ablation system, designed for the treatment of atrial fibrillation, consists of a versatile, multi-configurable (circular, linear, focal) ablation catheter and CSE ablation generator. The CSE ablation system employs phased sine waves to deliver pulsed field energy providing unipolar, bipolar, and combination energy delivery modes. #ArgaMedtech #NextGenerationsCardiacAblation #PFA #BURST-AF #KBCSplit Giorgi Papiashvili #MedicalResearchClinicTbilisi #KBCZagreb #AFS Advent Life Sciences Earlybird Venture Capital Gilde Healthcare Argá Medtech SA #AFSymposium2025