MARLBOROUGH, Mass.– CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for cardiac arrhythmias, today announced the first series of patients treated with the investigational OptiShot™ Pulsed Field Ablation (PFA) System for the treatment of paroxysmal atrial fibrillation as part of the VISION AF clinical trial.
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 at Na Homolce Hospital, Prague, Czech Republic. The first-in-human trial will treat up to 50 patients in the coming months with 12-month follow-up planned, including critical remapping procedures to validate the efficacy of this novel technology.
“The OptiShot balloon catheter is unique among the advanced generation of PFA catheters, with its ability to deliver circumferential lesions to the pulmonary veins with endoscopic visual confirmation of electrode-tissue contact,” said Dr. Reddy. “Direct contact confirmation made me more confident that our acute treatment strategy with this system may provide good long-term outcomes.”
Professor Petr Neužil said, “The ultra-compliant balloon allows for adaptation to all anatomies with unparallelled tissue contact and precise pulsed electric field energy delivery. This design is focused on raising the bar for patient outcomes and we look forward to continuing the study.”
“CardioFocus has combined our expertise in pulsed field waveforms with our clinically proven compliant balloon system to create OptiShot, a next generation PFA system for the treatment of atrial fibrillation,” said CardioFocus CEO Steve Ogilvie. “We are one step closer toward providing a true single shot pulmonary vein isolation tool, designed for safe and effective patient treatment. We are thankful to our electrophysiologist partners as well as the CardioFocus team and advisors for making this remarkable achievement happen.”
CardioFocus is taking a portfolio approach to PFA. In addition to OptiShot, CardioFocus will continue clinical trials evaluating the investigational QuickShot™ PFA System, a large area focal ablation catheter that integrates with various navigation technologies. In the EU CardioFocus has treated over 6000 patients with the Centauri PFA System, which uses a proprietary monopolar waveform with marketed contact-force sensing focal ablation catheters and mapping systems.
The OptiShot PFA Balloon System is investigational and not approved for commercial use.
