Kardium Announces Completion of Paroxysmal Enrollment in the PULSAR IDE Study

2024-04-02

临床研究

VANCOUVER, British Columbia--(BUSINESS WIRE)--Kardium Inc., a private medical device company that has developed the Globe® System for the treatment of atrial fibrillation (AF) using pulsed field ablation (PFA), announced today the successful completion of enrollment in the paroxysmal cohort of the pivotal PULSAR IDE (Investigational Device Exemption) study. This achievement marks a significant milestone in the journey to bring this groundbreaking technology to patients in the United States, with data from the study to be submitted to the Food and Drug Administration (FDA) for Pre-Market Approval (PMA). This press release features multimedia. View the full release here: The Globe mapping and ablation catheter from Kardium. (Photo: Business Wire) The PULSAR IDE study, an international, multi-center clinical trial, is designed to evaluate the safety and effectiveness of the Globe System for the treatment of atrial fibrillation. The successful completion of enrollment underscores the commitment of the clinical sites, investigators, and the entire Kardium team. “Reaching this milestone is a significant achievement," said Dr. Vivek Reddy of Mount Sinai Hospital, New York, 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." Dr. Atul Verma from McGill University Health Centre, Montreal, and co-principal investigator said, "The ability of the Globe System to deliver PF 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, expressed his gratitude to the patients, study investigators, and team members whose efforts have made this achievement possible. "The completion of enrollment 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." As the PULSAR study progresses toward its final stages, Kardium remains dedicated to its mission of developing a complete solution for the treatment of atrial fibrillation and improving patient care. The company eagerly anticipates the potential to improve the lives of millions of patients worldwide suffering from atrial fibrillation. The Globe System features the revolutionary 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. About Kardium Kardium Inc. (kardium.com) is a rapidly growing, privately held medical solutions company that has developed an advanced system for atrial fibrillation (AF) treatment: the Globe® System. Kardium has built an outstanding team, who have worked with top medical advisors to develop the Globe System. Founded in 2007 and headquartered in Vancouver, Canada, Kardium has consistently ranked as one of the top companies to work for in British Columbia. This press release may contain forward-looking statements, which reflect current expectations regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, performance or achievements to be materially different from those expressed or implied by such statements.

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