On LinkedIn, Nick Spadea-Anello, the company’s president of Electrophysiology, announced the enrollment in the trial. He said Dr. Oussama Wazni, global principal investigator, and his team at the Cleveland Clinic enrolled the first patients.
“I’m proud to share that Boston Scientific enrolled the first patients in the OPTIMIZE randomized controlled trial,” he wrote. “This trial uses the novel Cortex OptiMap electrographic flow (EGF) mapping technology with the Farapulse pulsed field ablation (PFA) platform to evaluate a source-guided ablation strategy in persistent atrial fibrillation.”
Marlborough, Massachusetts-based Boston Scientific acquired Cortex and its FDA-cleared OptiMap system about a year ago. The system helps to guide physicians performing ablation procedures to treat AFib. OptiMap uses a 64-electrode basket catheter and a proprietary algorithm to identify potential active AFib sources. It delivers precise insights to efficiently deliver an individualized ablation strategy for a person with AFib.
Ajax Health, a private-equity-backed medtech innovation accelerator, launched Cortex in 2023.
Using its algorithm, OptiMap can identify AFib. sources to bring physicians beyond anatomic ablation strategies to deliver personalized treatment with Boston Scientific’s Farapulse PFA system. Farapulse, one of the leading PFA systems for treating AFib, received a much-anticipated FDA approval last year. It earned expanded approval in July. The system treats AFib by delivering pulsed field energy through a catheter to ablate heart tissue.
