CardioFocus, Inc., a medical device company dedicated to advancing pulsed field ablation (PFA) treatment for cardiac arrhythmias, announced major advancements across its PFA portfolio.

OptiShot™ – Unique single shot PFA balloon catheter for pulmonary vein isolation (PVI):

• Late-breaking clinical presentation of first-in-human (FIH) data from the VISION AF trial by Dr Vivek Reddy on February 5 at the 2026 AF Symposium in Boston
• Initiation of site recruitment for OptiWave global IDE study

QuickShot™ Nav– Large-area focal PFA map-and-ablate catheter for complex arrhythmias:

• Live case with magnetic tracking on February 6 presented by Dr Ante Anić at the 2026 AF Symposium in Boston
• Expansion of sites for the ongoing Quick AF CE Mark pivotal study
• Initiation of site recruitment for the QuickWave global IDE study

CardioWave™ – Next-generation modular PFA generator

• Running all CardioFocus clinical projects and can support focal, large area focal, regional, and single shot catheter systems for current and future PFA requirements
• Demonstrated compatibility across all major mapping and navigation systems
• Compact design to accommodate all EP lab configurations

“These milestones reflect a dedication to patient safety, outcomes, and pulsed field waveform science, along with steady execution and strong investigator engagement,” said Steve Ogilvie, Chief Executive Officer of CardioFocus.

“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.”

The Quick AF CE Mark phase – evaluating QuickShot Nav with CardioFocus’ next-generation CardioWave PFA System – began in November 2025 at KBC Split in Split, Croatia and recently expanded to include Homolka Hospital in Prague, Czechia and St. Anne’s University Hospital in Brno, Czechia. Investigators at Homolka successfully performed the first fluoroless PVI+ procedures using QuickShot, underscoring workflow flexibility and the system’s ability to integrate seamlessly with multiple mapping and navigation systems, including EnSite™ X, OPAL HDx™, and CARTO™ 3.

At the AF Symposium 2026, scientific momentum at the meeting will be highlighted by a late-breaking clinical presentation of FIH acute and remapping data from the VISION AF trial evaluating endoscopically guided PVI with the OptiShot PFA balloon catheter. Additionally, CardioFocus will be collaborating with electrophysiologists from around the world to focus on site recruitment for its upcoming global IDE studies evaluating QuickShot and OptiShot with the CardioWave System.

On February 5 at 5:10 PM, Dr. Vivek Reddy will present:

“Visually-Guided Pulsed Field Ablation for Durable Pulmonary Vein Isolation: First-in-Human Acute & Chronic Remapping Results of VISION-AF.”

“The VISION AF data provides important early insights into how direct visualization of tissue contact may contribute to durable pulmonary vein isolation with PFA,” said Dr. Vivek Reddy.

“First-in-human acute and chronic remapping results are a critical step in evaluating lesion durability, and these findings help inform how visually guided PFA may contribute as the field continues to advance.”

In addition, CardioFocus’ PFA technology will be featured in a case presentation on February 6, showcasing PVI+ ablation guided by the VERAFEYE™ 2D/4D Cardiac Visualization System manufactured by LUMA Vision, performed by Ante Anić, MD, KBC Split in Split, Croatia. The case will demonstrate the magnetic integration and tracking capabilities of the QuickShot Nav catheter.

Together, these clinical, scientific, and integration milestones reflect CardioFocus’ differentiated approach to PFA — incorporating waveform design, catheter engineering, contact detection and advanced visualization to support confident lesion delivery and durable outcomes.

About CardioFocus, Inc.

Headquartered in Marlborough, MA, CardioFocus is a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation, the most common heart arrhythmia. For more information, visit CardioFocus.com.

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"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," said Steve Ogilvie, CEO of CardioFocus