Medtronic (NYSE:MDT) announced today that it won FDA approval to move forward with an investigational device exemption trial to evaluate the safety and effectiveness of its PulseSelect pulsed-field ablation (PFA) system.
The PulseSelect system is designed to use the pulsed electric fields to treat atrial fibrillation (Afib). It uses the fields to ablate or create lesions and scar tissue, interrupting irregular electrical pathways in the heart and the triggers of Afib. Unlike traditional methods, PFA treatment is non-thermal and selectively targets cardiomyocytes (heart muscle cells) while avoiding other types of tissue, according to a news release.
Medtronic won FDA breakthrough device designation for the PFA technology in September 2018 and, under the new IDE approval, is conducting the Pulsed AF multi-center, non-randomized, unblinded worldwide study for patients to be treated with the PulseSelect system.
The first procedures in the trial were performed last month by Dr. Bradley Wilsmore at John Hunter Hospital in New Lambton Heights, NSW, Australia, then in January by Dr. Atul Verma (the study’s principal investigator) at Southlake Regional Health Centre in Newmarket, Canada.
“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,” Verma said in the news release. “The rigorous pre-clinical research to get us to these first procedures has been impressive and we are excited to support the development of more clinical evidence.”