Argá Medtech Launches Pivotal IDE Trial for Its Multi-Configuration PFA Catheter Enabling Circular, Linear, and Focal Ablation in Atrial Fibrillation

Sep 22, 2025 22:16 CST Updated 22:16

Argá Medtech

Medical Device Developer

Argá MedtechAnnouncing its next-generation pulsed field ablation system---Coherent Sine-Burst Electroporation（CSE）The first patient has been enrolled in the COHERENT-AF clinical trial.

COHERENT-AF is an FDA-approved Investigational Device Exemption (IDE) pivotal study, utilizing a prospective, non-randomized design to evaluate the safety and efficacy of CSE in treating patients with paroxysmal and persistent atrial fibrillation. A total of 360 patients will be enrolled across multiple centers in the United States and Europe.

PI Evaluation

"The flexibility of CSE fills the treatment gap beyond pulmonary vein isolation. Its innovative guidewire-driven multi-configuration ablation catheter can easily achieve both linear and focal ablation, enhancing the efficiency of treating paroxysmal and persistent atrial fibrillation while further improving surgical safety by avoiding catheter changes."

---Ante Anic KBC Split Hospital

Executive Evaluation

"Launching the COHERENT-AF study marks a significant milestone for Argá Medtech, officially beginning our journey to provide a new generation of safe, rapid, and efficient ablation treatments for millions of patients with atrial fibrillation."

---David Neale Argá MedtechChief Executive Officer

In the middle of the yearArgá Medtech AnnouncesCSEEarly clinical studies have shownCSEAblation achieved durable isolation of the pulmonary veins, posterior wall, and CTI with a low complication rate.

Specific Research Results

At 6 months post-operation, 92.6% (63/68 cases) of patients had no recurrence of atrial arrhythmia.

94.7% of patients with paroxysmal atrial fibrillation (whether or not using antiarrhythmic drugs) had no recurrence of atrial arrhythmia.

90% of patients with persistent atrial fibrillation reached the same efficacy standard.

Only 1 case of renal insufficiency was reported as a major safety event.

CSE

CSEIt is a unique PFA ablation technology that adoptsArgó MedtechExclusiveSineWave, rather than traditional PFA technologySquare wave. ThereforeCSEAlso beenArgó MedtechHailed as the next-generation PFA technology.

Energy Waveform of CSE

Monopolar --- In-phase (0°)

Enhance Lesion Depth in Creating Focal Lesions

Bipolar --- 180° Phase Difference

Filling the gaps between electrodes when creating circular and linear lesions

Combined Energy Transfer — 0180° Phase Adjustment

When creating circular and linear lesions, it not only fills the electrode gaps but also enhances depth more effectively than the simple bipolar mode.

Square Wave of Traditional PFA Technology

According toArgó MedtechIntroductionCSEUsing sine waves has many advantages, such as

Sine wave titratable bipolar-unipolar ratio for lesion depth, lesion filling, and muscle excitation control
The sine wave generator uses a transformer circuit, providing unparalleled electrical isolation for the patient.

CSEIn addition to innovating in PFA energy, advancements have also been made in ablation catheters.CSEThe ablation catheter is a multi-purpose ablation catheter.CSEAblation CatheterCan be shaped to produce annular, linear, and focal ablation lesions.

Due toCSEThe multi-purpose characteristics of the ablation catheter simplify the surgical process and reduce the need for intraoperative catheter replacement.Reduces the risk of introducing air bubbles when removing one catheter and reinserting another, and reduces costs.

ArgáMedtech

ArgáMedtechArgá Medtech is an innovative medical device company established in 2020. It is developing a sine wave PFA technology for the treatment of patients with arrhythmia.