CardioFocus Launches CE Registration Clinical Study for QuickShot Nav Balloon-Based Large-Area Focal PFA Catheter and CardioWave Energy Platform

Nov 12, 2025 22:10 CST Updated 22:10

CardioFocus

Cardiac Medical Device Manufacturer

CardioFocusToday, its Pulsed Field Ablation (PFA) project has achieved a series of significant advancements and has officially started.QuickShot NavClinical Study for CE Registration of Large-Area Focal PFA Ablation Catheter and Next-Generation Electropulse Energy Platform CardioWave. The first group of patients has completed clinical enrollment.

PI Evaluation

"It is an honor to be the first center to conduct this important research. QuickShot ingeniously integrates efficient PFA energy delivery with real-time contact monitoring, while the CardioWave generator allows us to fully explore the potential of PFA through adjustable dosing and rapid output, providing better solutions for patients requiring treatment for complex lesion sets. This is an exciting advancement for both atrial fibrillation patients seeking interventional therapy and electrophysiologists."

---Ante Anić KBC Split

Executive Evaluation

"These achievements mark significant progress in our efforts to elevate the standards of PFA therapy. With the official launch of clinical trials for patients with persistent atrial fibrillation, the successful release of the CardioWave generator, and our successful integration with magnetic tracking technology, we have not only further solidified the scientific foundation of our technology but also paved the way for the development of safer and more user-friendly ablation technologies—applicable to various types of catheters."

---Steve Ogilvie CEO of CardioFocus

QuickShot Nav

QuickShot NavIs a largeFocal Mapping PFA Ablation Catheter with Area Coverage, Designed for Rapid and Efficient PFA Lesion Creation in Thick Myocardial Tissue Regions While Providing Physicians with Cross-Platform Real-Time Contact Detection and Mapping Capabilities.QuickShot NavThe multifunctional design makes the PVI+ (Pulmonary Vein Isolation and Extension) ablation process efficient and operationally simplified during ablation, allowing for flexible lesion planning with fewer procedural steps. It is equipped with a magnetic navigation sensor and is compatible with a magnetic positioning electrophysiological mapping system.

In the initial surgery,QuickShot NavSuccessfully adapted to multiple cardiac mapping and navigation systems, demonstrating excellent cross-platform compatibility.

CardioWaVE isCardioFocus's Second-Generation PFA EnergyThe platform features customizable waveform output, seamless workflow integration, and a scalable architecture, reserving room for the development of future advanced waveform technologies. It is compatible with the full range of CardioFocus catheters, including the OptiShot, a single-shot PFA balloon catheter for pulmonary vein isolation currently in clinical trials.

CardioFocus

CardioFocusIs a medical device innovator and manufacturer dedicated to advancing ablation treatments for the most common arrhythmias, such as atrial fibrillation (AFib).