The company will enrol up to 500 patients in non-randomised and multi-centre clinical study
Medtronic has completed the first procedures with the PulseSelect pulsed field ablation (PFA) system in the investigational device exemption (IDE) pivotal study.
PulseSelect is a novel technology designed to use pulsed electric fields to treat atrial fibrillation (AF).
Dr Nitesh Sood has performed the first procedure with PulseSelect at Southcoast Health in Fall River, Massachusetts. Dr Arnoldas Giedrimas conducted the second procedure at Southcoast Health.
Using a non-thermal approach, Medtronic’s system preferentially targets heart tissue to eliminate unwanted injury to surrounding structures.
The system, which is exclusively developed at Medtronic, provides electric fields through an ablation catheter designed specifically to interrupt irregular electrical pathways in the heart that trigger atrial fibrillation.
The IDE-approved PULSED AF study is said to be the first global, pre-market and multi-centre clinical trial designed to establish the safety and efficacy of the PulseSelect system.
Medtronic will enrol up to 500 patients in a prospective, non-randomised and multi-centre clinical trial at up to 50 sites in the US, Canada, Europe, and Australia.
The trial will assess the safety and efficacy of the PulseSelect system to treat AF in adult patients with a history of drug refractory, recurrent and symptomatic paroxysmal or persistent AF. Patients will be evaluated at six and 12 months.
Medtronic cardiac and vascular group’s cardiac ablation solutions chief medical officer Dr Rob Kowal said: “For years, Medtronic has been an active leader in the investigation of the safety and efficacy of pulsed field ablation.
“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.”
In 2018, the company secured breakthrough device status from the US Food and Drug Administration (FDA) for the PulseSelect technology to treat drug refractory recurrent symptomatic atrial fibrillation.