Medtronic secures FDA approval for PulseSelect PFA system trial

24 January 2020 (Last Updated January 24th, 2020 09:12)

Medtronic has secured approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) trial to assess PulseSelect pulsed-field ablation (PFA) system that employs pulsed electric fields to treat atrial fibrillation.

Medtronic secures FDA approval for PulseSelect PFA system trial
Medtronic provides various medical technologies for the treatment of cardiovascular disease and cardiac arrhythmias. Credit: Medtronic plc.

Medtronic has secured approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) trial to assess PulseSelect pulsed-field ablation (PFA) system that employs pulsed electric fields to treat atrial fibrillation.

PULSED AF trial will assess the safety and effectiveness of the PulseSelect PFA solution.

It is a prospective, multi-centre, non-randomised, unblinded study across the world that will register patients treated with the company’s PulseSelect PFA system.

Last December, the first procedure in the trial was carried out by Dr Bradley Wilsmore at John Hunter Hospital in New Lambton Heights, New South Wales, Australia.

Later this month, the principal investigator of the trial 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.”

The PFA utilises pulsed electric fields to ablate or develop lesions and scar tissue to disrupt irregular electrical pathways in the heart and the triggers of atrial fibrillation.

PFA is non-thermal and selectively targets cardiomyocytes in comparison to traditional methods of ablation that heat or cool the tissue.

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 arrhythmias, 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 September 2018, Medtronic had secured breakthrough device designation from the FDA for the PFA technology to treat drug-refractory recurrent symptomatic atrial fibrillation.

Across the world, the PFA system is investigational and not approved for sale or distribution.

Recently, Medtronic received CE Mark approval for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.