CardioFocus recently announced the successful completion of the first set of treatments in the OptiShot pulsed-field ablation system study. This work is part of the VISION AF clinical trial, aiming to assess OptiShot’s efficiency in addressing paroxysmal AFib. Dr. Vivek Reddy from Mount Sinai alongside Dr. Petr Neužil from Prague’s Na Homolce Hospital conducted the inaugural procedures. The ongoing study anticipates treating up to 50 patients, each observed over a 12-month period, featuring essential remapping operations to confirm the technology’s effectiveness.
Based in Marlborough, Massachusetts, CardioFocus has crafted the OptiShot device to create circumferential lesions around the pulmonary veins with endoscopic visual verification of electrode contact to the tissue, as highlighted by Dr. Reddy. Reddy emphasized that seeing direct contact reassured him regarding the long-term results.
Dr. Neužil praised the “ultra-compliant balloon” for its adaptability to various anatomies, noting its unmatched tissue contact and accurate pulsed electric field energy application.
“The design aims to elevate patient outcomes,” Neužil stated.
CardioFocus CEO Steve Ogilvie remarked: “CardioFocus has united our pulsed field waveform expertise with our clinically validated compliant balloon system for OptiShot, our advanced PFA system aimed at atrial fibrillation treatment. We are moving closer to delivering a true single-shot pulmonary vein isolation tool, tailored for reliable and secure patient care. We appreciate our electrophysiologist collaborators and the CardioFocus team, alongside our advisors, for this outstanding progress.”
Additionally, the company highlights a comprehensive approach to PFA, with the QuickShot PFA system, a wide-range focal ablation catheter, currently under review.