VANCOUVER, British Columbia--(BUSINESS WIRE)--Kardium Inc., a private medical device company that has developed the Globe® PF System for the treatment of atrial fibrillation (AF) using pulsed field ablation (PFA), announced today that the first patients have been successfully treated in its PULSAR clinical study. The international, multicenter study recently received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval in the United States, Health Canada approval in Canada, and SUKL approval in the Czech Republic, to validate the safety and effectiveness of the Globe System.
The PULSAR study will enroll over 400 patients for treatment at up to 35 sites in the United States, Canada, and Europe. Dr. Vivek Reddy (Mt. Sinai Hospital, New York) and Dr. Atul Verma (McGill University Health Centre, Montreal) are the principal investigators on the study. The first patients were treated this past week at Na Homolce Hospital, Prague, by Dr. Reddy, Prof. Petr Neužil, and Dr. Jan Petru.
The study expands on the successful Globe System first-in-human trial (PULSE-EU) of 69 patients. The initial results of the PULSE-EU study were recently published in JACC-EP. These results demonstrated 100% acute pulmonary vein isolation (PVI) and 100% durable isolation at 3-month remapping in patients who received an optimized PFA dose.
“From our experience with the PULSE-EU study, we have found the Globe System can provide a rapid and durable treatment of atrial fibrillation and has so far demonstrated exceptional rates of effectiveness,” said Dr. Vivek Reddy, MD, Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital. “I am excited to begin treating patients in the PULSAR IDE study.”
“The Globe System’s capabilities to deliver rapid PVI and customized PF lesions outside of the pulmonary veins, combined with high-definition mapping and real-time tissue contact maps, allow me to deliver a comprehensive treatment to patients,” said Dr. Atul Verma, MD, FRCPC, Associate Professor, McGill University, McGill University Health Centre. “The PULSAR study will expand our knowledge in the exciting and rapidly developing field of PF.”
“The whole team at Kardium is thrilled to be starting the PULSAR study,” said Kardium CEO Kevin Chaplin. “We believe the Globe System has the potential to improve outcomes for patients with atrial fibrillation, while also making the procedures easier for physicians.”
The Globe PF 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 PF energy to the heart. The Globe catheter sensors provide proprietary CONTACT™ maps to identify electrodes in contact with cardiac tissue, helping ensure therapy for atrial fibrillation is effectively delivered.
The PULSAR clinical trial will be used to validate the safety and effectiveness of the Globe System for regulatory approval and commercial sale.
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® PF System. Kardium has built an outstanding team, who have worked with top medical advisors to develop the Globe PF 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.