Medtronic (NYSE:MDT) announced today that it conducted the first procedures of its Pulsed AF AFib treatment pivotal trial.
The investigational device exemption (IDE) trial is evaluating the PulseSelect pulsed field ablation (PFA) system that uses pulsed electric fields to treat atrial fibrillation. The FDA granted the company approval to move forward with the IDE trial to evaluate the safety and effectiveness of the PulseSelect in January 2020.
Fridley, Minn.-based Medtronic’s platform uses the electric fields to ablate or create lesions and scar tissue, interrupting irregular electrical pathways in the heart and the triggers of AFib. Unlike traditional methods, PFA treatment is non-thermal and selectively targets cardiomyocytes (heart muscle cells) while avoiding other types of tissue.
According to a news release, Dr. Nitesh Sood performed the first procedure in the trial at Southcoast Health in Fall River, Mass. Dr. Arnoldas Giedrimas performed the second procedure at the same location.
Pulsed AF is a prospective, non-randomized, multi-center clinical trial set to enroll up to 500 patients to be treated with PulseSelect across as many as 50 sites in the U.S., Canada, Europe and Australia. Patients with a history of drug-refractory, recurrent and symptomatic paroxysmal or persistent AFib will be assessed at six and 12 months.
Results from the Pulsed AF pilot study were presented at Heart Rhythm Society 2020 Science with additional evidence shared at the AF Symposium earlier this year revealing 100% acute efficacy and no device or procedural-related events in the pilot cohort of patients treated with PulseSelect.
“For years, Medtronic has been an active leader in the investigation of the safety and efficacy of pulsed-field ablation,” Dr. Rob Kowal, CMO of Medtronic’s cardiac ablation solutions business, said in the release. “Developed internally at Medtronic, the PulseSelect system has the potential to create a paradigm shift in how cardiac ablations are performed for patients suffering from atrial fibrillation.”