MARLBOROUGH, Mass. — CardioFocus, a medical device company focused on advancing pulsed field ablation technology for the treatment of cardiac arrhythmias, announced new clinical milestones across its pulsed field ablation portfolio, including late-breaking data presentations and expanded global clinical programs to be highlighted at AF Symposium 2026 in Boston.
Company leadership said the symposium will serve as a key forum to showcase progress across CardioFocus’ catheter and generator platforms, as well as to engage clinical partners interested in participating in upcoming studies.
“Our teams and clinical partners are moving quickly to advance our unique PFA portfolio, and AF Symposium represents a key opportunity to share our progress, highlight new data, and engage with sites interested in participating in the next phases of our clinical programs,” said Steve Ogilvie, chief executive officer of CardioFocus.
Among the developments, CardioFocus will present first-in-human data from the VISION AF trial evaluating its OptiShot single-shot pulsed field ablation balloon catheter for pulmonary vein isolation. The late-breaking clinical presentation will be delivered on February 5 by Vivek Reddy, MD, and will include acute and chronic remapping results. In parallel, the company has initiated site recruitment for the OptiWave global investigational device exemption study.
The company is also advancing its QuickShot Nav platform, a large-area focal map-and-ablate catheter designed for complex arrhythmias. A live case presentation featuring magnetic tracking is scheduled for February 6 and will be presented by Ante Anić, MD. CardioFocus has expanded enrollment sites for the ongoing Quick AF CE Mark pivotal study and has begun site recruitment for the QuickWave global IDE study.
CardioFocus’ next-generation CardioWave pulsed field ablation generator is supporting all current clinical projects and is designed to accommodate focal, large-area focal, regional, and single-shot catheter systems. The company said the generator has demonstrated compatibility with major mapping and navigation systems and features a compact design intended to fit a wide range of electrophysiology lab configurations.
“These milestones reflect a dedication to patient safety, outcomes, and pulsed field waveform science, along with steady execution and strong investigator engagement,” Ogilvie said.
The Quick AF CE Mark phase began in November 2025 at KBC Split in Split, Croatia, and has since expanded to include Homolka Hospital in Prague and St. Anne’s University Hospital in Brno, Czechia. Investigators at Homolka recently completed the first fluoroless pulmonary vein isolation plus procedures using the QuickShot Nav catheter, highlighting workflow flexibility and integration with multiple mapping and navigation platforms.
At AF Symposium 2026, CardioFocus will also collaborate with electrophysiologists from around the world to support site recruitment for upcoming global IDE studies evaluating both QuickShot and OptiShot in combination with the CardioWave system.
During the February 5 presentation, Reddy will discuss how visually guided pulsed field ablation may contribute to durable pulmonary vein isolation, drawing on first-in-human acute and chronic remapping results from the VISION AF trial. He said the findings provide important early insights into lesion durability as pulsed field ablation technologies continue to evolve.
In addition, the company’s technology will be featured in a February 6 case presentation demonstrating pulmonary vein isolation plus ablation guided by an advanced cardiac visualization system, performed by Anić at KBC Split. The case will highlight magnetic integration and tracking capabilities of the QuickShot Nav catheter.
Company officials said the combined clinical, scientific, and system integration milestones underscore CardioFocus’ differentiated approach to pulsed field ablation, integrating waveform design, catheter engineering, contact detection, and advanced visualization to support durable clinical outcomes.
