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.