CardioFocus, Inc., a medical device company focused on advancing ablation treatments for cardiac arrhythmias, has announced the successful treatment of the first group of patients using the investigational OptiShot™ Pulsed Field Ablation (PFA) System. This marks a significant milestone in the VISION AF clinical trial, which is evaluating the system for the treatment of paroxysmal atrial fibrillation.
Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai Hospital, and Prof. Petr Neužil, Chief of Cardiology at Na Homolce Hospital, performed the first cases using the investigational OptiShot™ Pulsed Field Ablation (PFA) System at Na Homolce Hospital in Prague, Czech Republic. This marks the beginning of the first-in-human trial, which will treat up to 50 patients in the coming months, with 12-month follow-up planned to include critical remapping procedures to validate the technology’s efficacy.
“The OptiShot balloon catheter stands out among advanced PFA catheters due to its ability to deliver circumferential lesions to the pulmonary veins with endoscopic visual confirmation of electrode-tissue contact,” said Dr. Reddy. “Being able to confirm direct contact gave me confidence that our acute treatment strategy with this system may lead to favorable long-term outcomes.”
Professor Neužil highlighted the benefits of the system’s ultra-compliant balloon, noting it allows for adaptation to various anatomies, ensuring unparalleled tissue contact and precise delivery of pulsed electric field energy. “This design aims to set a new standard for patient outcomes, and we are eager to continue the study,” he added.
CardioFocus CEO Steve Ogilvie expressed excitement about the OptiShot system, saying, “We’ve combined our expertise in pulsed field waveforms with our clinically proven compliant balloon system to create the OptiShot PFA system, a next-generation solution for atrial fibrillation. We’re closer to offering a true single-shot pulmonary vein isolation tool for safe and effective patient treatment. We are deeply grateful to our electrophysiologist partners, as well as our CardioFocus team and advisors, for helping us reach this significant milestone.”
In addition to the OptiShot system, CardioFocus is continuing clinical trials for its QuickShot™ PFA System, a large-area focal ablation catheter that integrates with various navigation technologies. CardioFocus has also treated over 6,000 patients in the EU with the Centauri PFA System, which employs a proprietary monopolar waveform combined with contact-force sensing focal ablation catheters and mapping systems.
The OptiShot PFA Balloon System is currently investigational and not approved for commercial use.
About CardioFocus, Inc.
Headquartered in Marlborough, MA, CardioFocus is a medical device innovator dedicated to advancing ablation treatments for cardiac disorders, including atrial fibrillation, the most common heart arrhythmia.
