Kardium has announced the successful completion of enrolment in the paroxysmal cohort of the pivotal PULSAR IDE (investigational device exemption) study of the Globe pulsed field ablation (PFA) system for the treatment of atrial fibrillation (AF).
This marks a milestone in the journey to bring this groundbreaking technology to patients in the USA, Kardium says in a press release, with data from the study to be submitted to the US Food and Drug Administration (FDA) for premarket approval (PMA).
The PULSAR IDE study, an international, multicentre clinical trial, is designed to evaluate the safety and effectiveness of the Globe system for the treatment of AF. The successful completion of enrolment underscores the commitment of the clinical sites, investigators, and the entire Kardium team, the company’s press release adds.
“Reaching this milestone is a significant achievement,” said Vivek Reddy (Mount Sinai Hospital, New York, USA), co-principal investigator of the PULSAR study. “The Globe system provides precise control over the ablation, enhancing our potential to improve patient safety and treatment outcomes. By integrating mapping and ablation into a single catheter, its design streamlines workflow.”
Atul Verma (McGill University Health Centre, Montreal, Canada) and co-principal investigator, said: “The ability of the Globe system to deliver pulsed field energy precisely to the area of interest stands out as a key differentiator. Its innovative design enhances our confidence in the durability of the ablation and our ability to improve patient safety.”
Kevin Chaplin, CEO of Kardium, said: “The completion of enrolment in the PULSAR study represents a major accomplishment for Kardium. It moves us closer to our goal of transforming the treatment for patients with atrial fibrillation worldwide. We are committed to working closely with the FDA during the PMA submission process to bring this state-of-the-art technology to the market.”
The Globe system features the Globe catheter with 122 gold electrodes, each of which can map the patient’s cardiac anatomy and electrical activity and deliver pulsed field energy to the heart. The Globe catheter sensors are used to create a proprietary Contact Map to identify electrodes in contact with cardiac tissue, helping to confirm the delivery of therapy.
