The PULSED AF study will assess the safety and effectiveness of the PulseSelect PFA technology to treat atrial fibrillation
Medtronic has secured approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) trial to assess the PulseSelect pulsed-field ablation (PFA) system.
The PULSED AF study will assess the safety and effectiveness of the PulseSelect PFA technology, which applies pulsed electric fields for the treatment of atrial fibrillation.
The trial is a prospective, multi-centre, non-randomised, unblinded and worldwide study, which will recruit patients who will be treated with the company’s PulseSelect PFA system.
In December 2019, Dr Bradley Wilsmore conducted the first procedure in the trial at John Hunter Hospital in New Lambton Heights, New South Wales, Australia.
This month, the trial’s principal investigator Dr Atul Verma also performed the procedure at Southlake Regional Health Centre in Newmarket, Canada.
Verma said: “This study will evaluate a new energy source that may treat atrial fibrillation and potentially address the risks that have been associated with other ablation technologies, such as unintended tissue damage.”
PFA technology applies pulsed electric fields to treat atrial fibrillation
The PFA applies pulsed electric fields to ablate or build lesions and scar tissue to disturb irregular electrical pathways in the heart and the triggers of atrial fibrillation.
PFA is non-thermal and selectively targets cardiomyocytes compared to unlike traditional methods of ablation that heat or cool the tissue.
In September 2018, Medtronic secured breakthrough device designation from the FDA for the PFA technology to treat drug-refractory recurrent symptomatic atrial fibrillation.
The PFA system, which is investigational, is not yet secured approval for sale or distribution in any part of the world.
Medtronic cardiac and vascular group’s atrial fibrillation solutions division general manager and vice president Rebecca Seidel said: “As a global leader in the treatment of cardiac arrythmias, Medtronic is constantly evaluating new and existing therapies to better meet the needs of patients and the physicians who care for them.
“The PULSED AF study is another example of our commitment to meaningful innovation and a major step forward in the development of a diverse set of therapy options for atrial fibrillation patients.”
In December 2019, Medtronic secured FDA approval or its Stealth Autoguide system, which is designed to be used in cranial procedures.