Medtronic plc Receives FDA Approval for Trial Evaluating New Energy Source with Pulsed Electric Fields to Treat Atrial Fibrillation
January 23, 2020 at 08:30 pm IST
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Medtronic plc announced that it received approval from the U.S. Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate the safety and effectiveness of the PulseSelect™ Pulsed Field Ablation (PFA) System, a new technology that uses pulsed electric fields to treat atrial fibrillation. First procedures in the trial were performed in December 2019 by Bradley Wilsmore, M.D., at John Hunter Hospital, New Lambton Heights, NSW, Australia and in January by Atul Verma, M.D., the principal investigator (PI) for the study, at Southlake Regional Health Centre in Newmarket, Canada. PFA uses pulsed electric fields to ablate or create lesions and scar tissue to interrupt irregular electrical pathways in the heart and the triggers of atrial fibrillation. However, unlike traditional methods of ablation that heat the tissue (radio frequency) or cool the tissue (cryo) to ablate, PFA is non-thermal and selectively targets cardiomyocytes (heart muscle cells) while avoiding other types of tissue. In September 2018, Medtronic was granted Breakthrough Device designation from the FDA for the PFA technology for the treatment of drug refractory recurrent symptomatic atrial fibrillation. Worldwide, the PFA system is investigational and not approved for sale or distribution. PULSED AF is a prospective, multi-center, non-randomized, unblinded and worldwide study that will enroll patients who will be treated with the Medtronic PulseSelect PFA System. In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
Medtronic plc is one of the world leaders in designing, manufacturing and marketing of medical equipment. Net sales break down by sector of activity as follows:
- general and minimally invasive surgery (28.8%): surgical equipment, intra-operative monitoring systems, ventilation systems, etc.;
- cardiac rhythm management (18.6%): implantable cardiac pacemakers, implantable defibrillators and automatic external defibrillators, cardiac ablation probes, etc.;
- vascular diseases and cardiac surgery (17.4%): coronary stents, endoprostheses for aortal pathologies, distal protection systems, catheters, heart valve prostheses, auto-transfusion equipment, cardiac ablation devices, etc.;
- spinal disorders (14.1%): spinal prostheses, disc prostheses, cerebral stimulation systems, bone graft technologies and mini-invasive spinal surgery, etc. The group also develops medical imagery-guided surgical navigation systems activity;
- neurovascular, ear, nose and throat (ENT) and pelvic diseases (8.2%);
- diabetes management (7.4%): internal and external glycemia monitoring systems and insulin pumps;
- neurological disorders (5.5%): neurostimulation and pumped medication administration products, diagnostic tools, etc.
Net sales are distributed geographically as follows: Ireland (0.3%), the United States (50.9%) and other (48.8%).
MEDTRONIC PLC 
