- Medtronic plc (MDT -2.8%) has announced the first procedures in the investigational device exemption (“IDE”) pivotal trial to evaluate the PulseSelect Pulsed Field Ablation System in atrial fibrillation.
- The first procedures were performed at Southcoast Health, the company said.
- Conducted in the U.S., Canada, Europe, and Australia, the prospective, non-randomized, multi-center clinical trial will enroll up to 500 patients with a history of drug-refractory, recurrent, and symptomatic paroxysmal or persistent AF.
- The company has disclosed the results of the PULSED AF pilot study at a late-breaking session at Heart Rhythm Society 2020 Science with additional evidence presented at the AF Symposium in January 2021.
- The results have highlighted 100% acute efficacy and no device or procedure-related events in the pilot cohort of patients.
- Medtronic announced the FDA signoff for the IDE trial in January 2020.