Biotronik Submits IPO Prospectus Highlighting ElePulse: First-in-Class 3D Helical PFA Catheter with 92% One-Year Atrial Fibrillation Freedom Rate

Nov 15, 2025 22:10 CST Updated 22:10

BIOTRONIK

Developer of Cardiac Rhythm Management and Vascular Intervention Medical Technologies

CardioFocus

Cardiac Medical Device Manufacturer

BiotronikAnnouncementIts3D Spiral PFA Ablation Catheter---ElePulseThe first patient has been successfully enrolled in the RESET AF 3D clinical study.RESET AF 3D Study is a CE-registered clinical study,Aimed to evaluateElePulseClinical manifestations in patients with atrial fibrillation (AF). The findings of this study will be used for ElePulse's CE registration application in Europe.

Expert Evaluation

"The surgical efficiency of the new ElePulse PFA system is remarkable, with its single-discharge, single-positioning design demonstrating outstanding performance, truly possessing the potential to simplify the atrial fibrillation ablation process."

---Vivey Reddy Mount Sinai Health System

"We are honored to have completed the enrollment of the first patient at our center. As a center dedicated to clinical research, we are pleased to contribute to the validation of this promising next-generation PFA technology."

---Petr Neužil Na Homolce Hospital

Nowadays, electrophysiology has entered the PFA era, and Europe is significantly lagging behind North America and East Asia in terms of PFA. There is basically no standout PFA product that comes to mind in Europe. The PFA market in Europe is largely monopolized by four major giants: Boston Scientific, Johnson & Johnson, Medtronic, and Abbott. Therefore, Europe urgently needs an electrophysiology company to break this monopoly.

BiotronikUndoubtedly the best candidate.BiotronikAt the beginning of the year, it was decided to transform, andVascular intervention business divested and sold to Teleflex. Focus shifts toElectrophysiology,Cardiac Rhythm Management,Neuromodulation.

ThereforeBiotronikBegan actively expanding into electrophysiology, reaching a strategic cooperation with CardioFocus in July this year to act as the sales agent in Europe.CardioFocus' PFA Energy Platform---Centauri. Of course, this is for Europe's largest electrophysiology company.BiotronikTo say is not its ultimate goal. The real way out is to independently develop advanced PFA technology, for this reasonBiotronikDeveloped the first proprietary PFA product---ElePulse。WithElePulseRelease,BiotronikFurther solidified its significant position in the rapidly growing field of atrial fibrillation treatment.

ElePulse
ElePulseIs the world's first single-discharge,Single-position Pulmonary Vein Isolation PFA Technique.ElePulseBy6Fr Linear Six-Pole Bidirectional Adjustable Catheter, 8Fr Bidirectional Adjustable3D Helical Multi-Electrode PFA Ablation CatheterComposition.
Among them, there are two specifications for the PFA ablation catheter.25mm and 30mm, with 16 electrodes on the 25mm distal end and 20 electrodes on the 30mm distal endBoth catheters can enter the left atrium through an 8.5Fr steerable sheath. When used with a pulsed field ablation generator, they can deliver microsecond, QRS-gated biphasic bipolar pulsed electric fields, supporting ablation through individually selected electrodes or all electrodes.

PFA Ablation CatheterAchieving durable, transmural pulmonary vein isolation and extra-venous continuous circumferential ablation by delivering ring-shaped pulsed electric fields — without the need to adjust catheter position throughout the procedure.ElePulseSeamlessly compatible with standard 8.5F sheaths and widely-used 3D mapping platforms, minimizing workflow interruptions and reducing operational complexity and training requirements.

ElePulse Clinical Efficacy

According toBiotronikIntroductionElePulseThe early study (enrolling 36 patients with atrial fibrillation) showed very significant treatment effects. Specific study inclusion criteria:

100% Acute Pulmonary Vein Isolation Rate
The 12-month AF recurrence-free rate was 92%.
Zero Heat-Related Complications

Expert Evaluation

"ElePulse achieves true single-shot ablation, with rapid operation, definitive efficacy, and good patient tolerance. This study will validate the system's ability to deliver durable atrial fibrillation treatment without adjusting the catheter position, which is of significant importance for simplifying clinical workflows."

---Petr Peichl Institute for Clinical and Experimental Medicine (IKEM)

BIOTRONIK

BIOTRONIK (BIOTRONIK) is a global leading medical technology company whose products and services can save and improve the lives of millions of people suffering from heart and vascular diseases as well as chronic pain. We are committed to perfectly matching technology with the human body and dedicated to developing trusted cardiovascular, endovascular, and neuromodulation solutions.