CardioFocus, Inc. has announced the treatment of the first patients using its investigational OptiShot Pulsed Field Ablation (PFA) System as part of the VISION AF clinical trial. The procedures, aimed at treating paroxysmal atrial fibrillation, were performed at Na Homolce Hospital in Prague, Czech Republic, by Dr. Vivek Reddy and Prof. Petr Neužil.
The VISION AF trial is set to enroll up to 50 patients and will include a 12-month follow-up period. This follow-up incorporates critical remapping procedures designed to validate the effectiveness of the OptiShot technology in achieving pulmonary vein isolation, a key objective in atrial fibrillation treatment.
The OptiShot system distinguishes itself with an ultra-compliant balloon catheter. According to Dr. Reddy, this balloon's design facilitates the delivery of circumferential lesions to the pulmonary veins, aided by endoscopic visual confirmation of electrode-tissue contact. He expressed confidence that this direct contact confirmation could lead to favorable long-term outcomes.
Professor Neužil emphasized the balloon's adaptability to various anatomies, ensuring optimal tissue contact and precise pulsed electric field energy delivery. He stated that the design is intended to elevate the standard for patient outcomes.
CardioFocus CEO Steve Ogilvie noted that the OptiShot system combines the company's expertise in pulsed field waveforms with its clinically proven compliant balloon system. He believes the OptiShot system represents a significant step toward providing a single-shot pulmonary vein isolation tool that is both safe and effective.
In addition to OptiShot, CardioFocus is also advancing the QuickShot PFA System, a large-area focal ablation catheter integrated with navigation technologies. The company has also treated over 6000 patients in the EU with the Centauri PFA System, which utilizes a monopolar waveform with contact-force sensing focal ablation catheters and mapping systems.
