Medtronic (NYSE:MDT) announced today that it completed patient enrollment its global pivotal Pulsed AF trial.
The Pulsed AF trial is evaluating the PulseSelect pulsed-field ablation (PFA) system in the prevention of the recurrence of AFib while avoiding unwanted injury to surrounding structures or tissue.
Fridley, Minnesota-based Medtronic conducted the first procedures of the Pulsed AF AFib treatment FDA investigational device exemption (IDE) trial in March after 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.
Medtronic designed PulseSelect to use electric fields to ablate or create lesions and scar tissue, interrupting irregular electrical pathways in the heart and the triggers of AFib. In contrast to traditional methods, PFA treatment is non-thermal and selectively targets cardiomyocytes (heart muscle cells) while avoiding other types of tissue in treating the common heart rhythm disorder.
The Pulsed AF trial has enrolled nearly 400 patients across more than 40 clinical sites in the U.S., Canada, Europe and Australia. It is also the first and only trial of its kind to study PFA in Japan, Medtronic said.
Patients enrolled in the Pulsed AF trial have a history of drug-refractory, recurrent and symptomatic paroxysmal or persistent AFib and will be treated with PulseSelect with assessments for safety and efficacy at six months and 12 months.