Aussie medtech reveals new data on next-gen pulsed field ablation system for atrial fibrillation

MedTech & Diagnostics News: An Australian-based medtech company announced promising results from the first-in-human study for its pulsed field ablation (PFA) system at the Heart Rhythm Society scientific meeting on May 19.

Nearly half of all patients hospitalised for atrial fibrillation (AF) in Australia and New Zealand do not survive beyond a decade. Despite the demonstrated efficacy of catheter ablation procedures, they remain vastly underutilised in treating this condition. The current market for PFA systems includes devices from Medtronic and Boston Scientific.

Sydney’s CathRx has designed ElectroPulse to treat symptomatic AF. The system comprises the ElectroPulse generator, a variable loop mapping and ablation catheter, and the ElectroTouch contact sensing module.

“CathRx’s ElectroPulse PFA catheter system is an exciting new advancement in the treatment of AF, with the very real prospect of improving both clinical and procedural outcomes beyond what’s already available,” said Professor Prash Sanders, Director of the Centre for Heart Rhythm Disorders at the University of Adelaide and Royal Adelaide Hospital, and the study’s principal investigator.

The loop mapping and ablation catheter allows physicians to perform the procedure with a single catheter, creating detailed pre- and post-ablation voltage maps. It enables precise ablation with a high-voltage, proprietary waveform, and confirms bi-directional electrical block. ElectroTouch provides real-time feedback, indicating direct contact between catheter electrodes and heart tissue. This guidance ensures precise energy delivery, helps create more targeted lesions, and reduces the risk of unintended ablation.

“We’ve started seeing some of the upsides from available PFA systems with regards to improved safety and faster procedures compared to older technologies. ElectroPulse may take these benefits even further and improve efficacy outcomes as well. Our early experience with the system in human trials has demonstrated that it certainly has the potential to do so,” Professor Sanders said.

CathRx stated that the all-in-one design streamlines the ablation process and minimises the need for additional catheters. The system integrates seamlessly with existing hospital equipment, reducing the need for additional capital investment.

The study enrolled both paroxysmal and persistent AFib patients and achieved a 100% success rate in isolating all four pulmonary veins and the posterior wall of the left atrium. Bi-directional electrical blocks were achieved in all patients. The company reported no serious adverse events in the study, and no significant blood cell destruction or kidney injury was observed. ElectroPulse delivered short procedure times with limited fluoroscopy.

CathRx CEO, Ian Fong, stated “This study marks a significant milestone for CathRx. The ElectroPulse Pulsed Field Ablation System represents a major leap forward in ablation technology. By leveraging our extensive experience in catheter development and incorporating a high-voltage, biphasic and bipolar pulse design with our proprietary high-voltage waveform, we’ve created a system that offers deep and potentially more durable lesions, with the potential to improve long-term patient outcomes for those suffering from AF.”

Last year, CathRx was awarded Australian Government funding through the Clinical Translation and Commercialisation MedTech (CTCM) program – a Medical Research Future Fund (MRFF) initiative delivered by MTPConnect. 

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