The VISION AF clinical trial evaluates OptiShot as a treatment for paroxysmal AFib. Dr. Vivek Reddy of Mount Sinai and Dr. Petr Neužil of Na Homolce Hospital (Prague) performed the first cases. The company expects the first-in-human study to treat up to 50 patients with a 12-month follow-up afterward. That includes critical remapping procedures to validate the efficacy of the novel technology.
Marlborough, Massachusetts-based CardioFocus designed OptiShot to deliver circumferential lesions to the pulmonary veins, Reddy says. This occurs with endoscopic visual confirmation of electrode-tissue contact, according to the doctor. According to Reddy, direct contact confirmation made him more confident in long-term outcomes.
Neužil says the “ultra-compliant balloon” enables adaptation to all anatomies. He also highlighted “unparalleled tissue contact and precise pulsed electric field energy delivery.”
“This design is focused on raising the bar for patient outcomes,” said Neužil.
“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.”
The company touts a portfolio approach to PFA, with its QuickShot PFA system, a large area focal ablation catheter, under evaluation.
