The IDE enables the Hayward, California–based company to initiate the NANOPULSE-AF study of its nPulse cardiac catheter ablation system. The study evaluates the company’s PFA technology in the treatment of paroxysmal AFib. This study could bring Pulse Biosciences one step closer to challenging in the PFA market, which features the likes of Medtronic, Boston Scientific and Johnson & Johnson MedTech.

The single-arm, multicenter, prospective study evaluates the primary safety and effectiveness of the nsPFA system in recurrent, drug-resistant symptomatic paroxysmal AFib. It includes up to 30 sites, including three outside the U.S. Pulse Biosciences intends to enroll up to 145 patients.