CathRx announced today that results from its first-in-human study support its ElectroPulse pulsed field ablation (PFA) system.
The Sydney, Australia-based company, which just emerged from stealth mode, designed ElectroPulse to treat symptomatic AFib. The system features the ElectroPulse generator, variable loop mapping and ablation catheter with the ElectroTouch contact sensing module.
According to a news release, the loop mapping and ablation catheter tool empowers physicians to perform the procedure with a single catheter. It allows for the creation of detailed pre- and post-ablation voltage maps. It also enables precise ablation with a high-voltage, proprietary waveform. Additionally, the same catheter confirms bi-directional electrical block.
ElectroTouch provides real-time feedback, indicating direct contact between catheter electrodes and heart tissue. This guides ablation decisions and ensures precise energy delivery where needed. By eliminating guesswork and confirming tissue contact, the module helps create more targeted lesions. That helps to improve efficacy and reducing the risk of unintended ablation.
Together, the all-in-one design streamlines ablation and minimizes the need for additional catheters, CathRx says. It seamlessly integrates with existing hospital equipment, minimizing the need for additional capital investment.
Details of the CathRx first-in-human study
CathRx enrolled both paroxysmal and persistent AFib patients and observed a 100% success rate in isolating all four pulmonary veins, as well as the posterior wall of the left atrium. The study also achieved bi-directional electrical blocks in all patients.
The company reported no serious adverse events in the study and no evidence of significant blood cell destruction or kidney injury. ElectroPulse delivered short procedure times with limited fluoroscopy.
CathRx plans to present its data at the Heart Rhythm Society scientific meeting on May 19. Dr. Prash Sanders, the study’s principal investigator, said ElectroPulse could potentially imporve both clinical and procedural outcomes beyond already available systems. That includes the PFA systems made by the likes of Medtronic and Boston Scientific.
“We’ve started seeing some of the upsides from available PFA systems with regards to improved safety and faster procedures compared to older technologies, however ElectroPulse may take these benefits even further and may improve efficacy outcomes as well,” Sanders said. “Our early experience with the system in human trials has demonstrated that it certainly has the potential to do so.”
CEO Ian Fong called the study “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 AFib.”
