Paroxysmal Enrollment in Kardium’s PULSAR IDE Study Completed

Kardium Inc. has finished enrolling patients in the paroxysmal cohort of its PULSAR IDE (Investigational Device Exemption) study, an international, multi-center clinical trial designed to evaluate the safety/effectiveness of the Globe System for atrial fibrillation treatment. 
 
“Reaching this milestone is a significant achievement,” said Dr. Vivek Reddy of Mount Sinai Hospital (New York, N.Y.), PULSAR’s co-principal investigator. “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.”

The Globe Pulsed Field Mapping and Ablation System is a multielectrode mapping and ablation solution consisting of a sophisticated catheter with 122 electrodes that provides rapid, single-shot pulmonary vein isolation (PVI) and the ability to quickly confirm PVI during ablation. The Globe System combines the rapid PVI of balloon catheters, the flexibility of single-tip catheters, and the HD mapping of multi-electrode catheters, according to the company. 

“The ability of the Globe System to deliver PF energy precisely to the area of interest stands out as a key differentiator,” stated Dr. Atul Verma from McGill University Health Centre (Montreal) and co-principal investigator. “Its design enhances our confidence in the durability of the ablation and our ability to improve patient safety.”
 
Each of the Globe System’s 122 gold electrodes 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.

“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,” Kardium CEO Kevin Chaplin said.
 
Kardium Inc. is a privately held medical solutions company that has developed an advanced system for atrial fibrillation (AF) treatment: the Globe System. The firm was founded in 2007 and is headquartered in Vancouver, Canada.