CardioFocus is a medical technology company specializing in advanced Pulsed Field Ablation (PFA) technologies for the treatment of complex cardiac arrhythmias. The company’s solutions are designed to provide electrophysiologists with greater precision, control, and confidence during cardiac ablation procedures. Built on more than two decades of balloon catheter innovation and over ten years of PFA waveform development, CardioFocus’s systems are grounded in rigorous science and designed to address a broad range of clinical needs.

CardioFocus’s PFA portfolio includes the Centauri™ System, a CE-marked generator available in the European Union, along with next-generation systems such as QuickShot Nav™, OptiShot™, and the CardioWave™ System. These platforms are engineered to support diverse ablation strategies across evolving electrophysiology workflows, while optimizing energy delivery and procedural efficiency and integrating seamlessly into clinical practices.

Headquartered in Marlborough, Massachusetts, CardioFocus is committed to advancing patient care through innovative, science-driven solutions that continue to expand the possibilities of PFA therapy. The company is pioneering the next generation of ablative technologies to support improved outcomes for patients with cardiac arrhythmias worldwide.

Technology

QuickShot® Nav

QuickShot® Nav is an investigational large-area focal Pulsed Field Ablation (PFA) system designed to treat complex cardiac arrhythmias. Engineered to deliver efficient focal ablation, the technology combines a large-area focal catheter design with advanced waveform science to create precise and effective lesions while providing electrophysiologists with greater procedural confidence.

The system integrates mapping and ablation into a single catheter, reducing the need for catheter exchanges while maintaining seamless compatibility with the CardioWave generator. QuickShot® Nav also incorporates a real-time contact detection interface that evaluates catheter-to-tissue engagement, providing clinicians with valuable procedural insights during ablation.

Designed with a 10-mm basket tip optimized for large-area energy delivery, QuickShot® Nav is intended to create consistent lesion depth and width, supporting durable ablation outcomes. The device is currently investigational and has not yet been approved for commercial use.

OptiShot™

OptiShot™ is an investigational single-shot Pulsed Field Ablation (PFA) balloon system designed for pulmonary vein isolation (PVI). Building on CardioFocus’s decades of experience in balloon catheter innovation, the technology combines adaptive balloon architecture with integrated direct visualization to support a simplified and efficient PFA workflow.

The system features an ultra-compliant, anatomy-adaptive balloon engineered to conform to a wide range of pulmonary vein anatomies, enabling consistent circumferential therapy from a single position. Integrated endoscopic imaging provides real-time visualization of electrode-to-tissue contact, helping clinicians deliver energy with greater confidence while supporting uniform lesion formation.

Designed to simplify pulmonary vein isolation procedures, OptiShot™ enables a single-position, circumferential PVI approach that reduces procedural complexity and supports efficient ablation workflows. The device is currently investigational and has not yet been approved for commercial use.

CardioWave™ System

The CardioWave™ System is an investigational next-generation Pulsed Field Ablation (PFA) generator that serves as the waveform engine for the CardioFocus PFA portfolio. Designed to address both current and future clinical needs, the system provides a flexible platform that supports a broad range of catheter technologies and evolving ablation strategies.

Built with a modular energy architecture, the CardioWave™ System powers diverse catheter designs and electrode configurations within a unified platform. It integrates CardioFocus’s extensive waveform science expertise with advanced catheter technologies to support effective and efficient energy delivery during ablation procedures.

Designed as a scalable platform, the CardioWave™ System is intended to support both current and future PFA technologies, adapting to emerging catheter designs and expanding clinical applications. The device is currently investigational and has not yet been approved for commercial use.

Centauri™ System

The Centauri™ System is a CE-marked Pulsed Field Ablation (PFA) platform available in select European Union countries and exclusively distributed by CardioFocus. Designed as an open-platform system, it integrates with existing focal contact force catheter workflows, enabling electrophysiologists to deliver durable PFA lesions while enhancing procedural efficiency, safety, and patient outcomes. The system is not commercially available in the United States.

The Centauri™ System features CardioFocus’s proprietary WAVE1 monopolar biphasic waveform, engineered to achieve transmural lesion formation while minimizing microbubble generation and muscle stimulation. The platform incorporates impedance-balanced energy delivery and a current control algorithm to provide consistent, predictable energy output across different patient anatomies. Physicians can select from three monopolar energy settings—19, 22, and 25 amps—providing greater control over lesion delivery based on tissue characteristics.

Built on an open-platform architecture, the Centauri™ System is compatible with several commercially available contact force ablation catheters and mapping systems, allowing seamless integration into established electrophysiology workflows. The platform combines proprietary waveform technology, monopolar energy delivery, automatic impedance monitoring, and current-controlled energy output to support consistent lesion formation while prioritizing procedural safety.

Clinical studies have demonstrated encouraging safety and efficacy outcomes, including no reported esophageal injuries, phrenic nerve injuries, pulmonary vein stenosis, or microbubble formation during evaluated procedures. In addition, studies have reported durable pulmonary vein isolation rates at three months across multiple compatible contact force ablation catheter platforms, highlighting the system’s ability to support effective atrial fibrillation ablation.

STEPHAN OGILVIE | CEO

Stephan Ogilvie is the Chief Executive Officer of CardioFocus, where he leads the company's strategy and operations as it advances next-generation Pulsed Field Ablation (PFA) technologies for the treatment of complex cardiac arrhythmias. Under his leadership, CardioFocus continues to expand its PFA portfolio, advance clinical programs, and strengthen strategic collaborations supporting the development of innovative electrophysiology solutions.