CardioFocus Announces First Enrollments in CE Mark Clinical Trial of QuickShot™ PFA Catheter and CardioWave™ PFA System

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MARLBOROUGH, Mass.--(BUSINESS WIRE)--Nov 11, 2025--

CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for cardiac arrhythmias, today announced a series of major milestones advancing its pulsed field ablation (PFA) program. The company has initiated its CE Mark pivotal clinical trial for the QuickShot™ Nav large-area focal PFA Catheter and the next-generation CardioWave™ PFA System. The first patients were enrolled at KBC Split in Croatia under the leadership of Dr. Ante Anić and included the first-ever magnetically tracked QuickShot cases.

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“We are thrilled to be the first center to initiate this important study,” said Dr. Ante Anić, Head of the Department of Electrophysiology at KBC Split. “QuickShot offers a unique opportunity to combine efficient PFA energy delivery with real-time contact information. The CardioWave Generator allows us to explore the full potential of PFA with adjustable dosing and rapid delivery to better treat patients with the complex lesion sets they need. This is an exciting advancement for electrophysiologists and patients with atrial fibrillation seeking interventional treatment.”

“These achievements represent meaningful advancements in our mission to elevate the standards of PFA therapy,” said Steve Ogilvie, CEO of CardioFocus. “With the start of our CE Mark clinical trial treating patients with persistent atrial fibrillation, the successful introduction of the CardioWave Generator, and our integration into magnetic tracking, we’re not only expanding the scientific foundation of our technology but also paving the way for safer, more intuitive ablation workflows across all catheter form factors.”

QuickShot is a large-area focal map-and-ablate catheter engineered to deliver rapid and effective PFA lesions, including in areas of thick tissue, while providing physicians with real-time contact detection and mapping functionality across multiple platforms. The new CardioWave System is a second-generation PFA platform designed for customized waveform delivery, seamless workflow integration, and scalable architecture to support future advanced waveforms. The new platform also supports all CardioFocus catheters, including OptiShot™, a true single-shot PFA balloon for pulmonary vein isolation that is currently in clinical trials.

In the initial procedures, QuickShot was successfully used with several cardiac mapping and navigation systems, demonstrating its multi-platform compatibility. This adaptability reinforces CardioFocus’ commitment to versatile PFA workflows that integrate seamlessly into today’s electrophysiology labs.

Together, these advancements strengthen CardioFocus’ position in delivering a platform of next-generation PFA technologies that combine intelligent waveform design, catheter versatility, and advanced visualization—driving forward the evolution of AF ablation therapy.

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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CONTACT: Media Relations

Pete Bell

[email protected]

KEYWORD: MASSACHUSETTS EUROPE UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: HEALTH MEDICAL DEVICES CARDIOLOGY

SOURCE: CardioFocus, Inc.

Copyright Business Wire 2025.

PUB: 11/11/2025 12:28 PM/DISC: 11/11/2025 12:28 PM

http://www.businesswire.com/news/home/20251111991136/en