Sam Brusco, Associate Editor03.04.21
Medtronic completed the first procedures in the investigational device exemption (IDE) pivotal trial to evaluate the PulseSelect Pulsed Field Ablation (PFA) System, which uses pulsed electric fields to treat atrial fibrillation (AF). The first procedure in the PULSED AF pivotal trial was performed this week at Southcoast Health by Nitesh Sood, M.D., Fall River, Massachusetts; the second procedure was performed by Arnoldas Giedrimas, M.D., also at Southcoast Health.
The PulseSelect System delivers pulsed electric fields through an ablation catheter that interrupts irregular electrical pathways in the heart that trigger AF. Unlike traditional ablation methods that heat or cool the atrial tissue, PulseSelect uses a non-thermal approach and preferentially targets heart tissue to avoid unwanted injury to surrounding structures.
"Based on the results we've experienced with the pilot trial, we are entering a new era for AF ablation techniques with this novel energy source," Atul Verma, M.D., electrophysiologist and head of arrhythmia services at Southlake Regional Health Centre in Newmarket, Canada and the principal investigator (PI) for the PULSED AF study told the press. "We are excited to begin the pivotal stage of the PULSED AF study and generate a larger body of clinical evidence to support the safety and benefits of pulsed field ablation."
The PULSED AF trial will enroll up to 500 patients who will be treated with the PulseSelect System across 50 sites in the U.S., Canada, Europe, and Australia. The trial will evaluate the PulseSelect System’s safety and efficacy in treating AF in adult patients with a history of drug refractory, recurrent and symptomatic paroxysmal or persistent AF. Patients will be assessed at six and 12 months.
"For years, Medtronic has been an active leader in the investigation of the safety and efficacy of pulsed field ablation," said Rob Kowal, M.D., Ph.D., chief medical officer of Cardiac Ablation Solutions, part of the Cardiac and Vascular Group at Medtronic. "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."
PulseSelect pre-clinical research included extensive work to understand the novel energy source’s physiology and mechanism of action, resulting in Breakthrough Device Designation in 2018 from the U.S. Food and Drug Administration (FDA) to treat drug refractory recurrent symptomatic AF.
Results of the PULSED AF pilot study were presented in a late-breaking session at Heart Rhythm Society 2020 Science and additional evidence was shared at the AF Symposium in January 2021, demonstrating 100 percent acute efficacy and no device or procedural-related events in the pilot cohort of patients. Worldwide, the PulseSelect system is investigational and not approved for sale or distribution.
The PulseSelect System delivers pulsed electric fields through an ablation catheter that interrupts irregular electrical pathways in the heart that trigger AF. Unlike traditional ablation methods that heat or cool the atrial tissue, PulseSelect uses a non-thermal approach and preferentially targets heart tissue to avoid unwanted injury to surrounding structures.
"Based on the results we've experienced with the pilot trial, we are entering a new era for AF ablation techniques with this novel energy source," Atul Verma, M.D., electrophysiologist and head of arrhythmia services at Southlake Regional Health Centre in Newmarket, Canada and the principal investigator (PI) for the PULSED AF study told the press. "We are excited to begin the pivotal stage of the PULSED AF study and generate a larger body of clinical evidence to support the safety and benefits of pulsed field ablation."
The PULSED AF trial will enroll up to 500 patients who will be treated with the PulseSelect System across 50 sites in the U.S., Canada, Europe, and Australia. The trial will evaluate the PulseSelect System’s safety and efficacy in treating AF in adult patients with a history of drug refractory, recurrent and symptomatic paroxysmal or persistent AF. Patients will be assessed at six and 12 months.
"For years, Medtronic has been an active leader in the investigation of the safety and efficacy of pulsed field ablation," said Rob Kowal, M.D., Ph.D., chief medical officer of Cardiac Ablation Solutions, part of the Cardiac and Vascular Group at Medtronic. "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."
PulseSelect pre-clinical research included extensive work to understand the novel energy source’s physiology and mechanism of action, resulting in Breakthrough Device Designation in 2018 from the U.S. Food and Drug Administration (FDA) to treat drug refractory recurrent symptomatic AF.
Results of the PULSED AF pilot study were presented in a late-breaking session at Heart Rhythm Society 2020 Science and additional evidence was shared at the AF Symposium in January 2021, demonstrating 100 percent acute efficacy and no device or procedural-related events in the pilot cohort of patients. Worldwide, the PulseSelect system is investigational and not approved for sale or distribution.
