First-in-Human Trial of Pulsed Field Ablation with Kardium’s Globe® PF System

Pulsed Field Ablation (PFA): Promising new therapy to treat the world’s most common heart rhythm disorder, atrial fibrillation (AF).

VANCOUVER, British Columbia--(BUSINESS WIRE)--Kardium Inc. announces the completion of successful first-in-human (FIH) procedures with the Globe Pulsed Field System.

Dr. Vivek Reddy of Mount Sinai Hospital in New York, USA and Prof. Petr Neužil of Na Homolce Hospital in Prague, Czech Republic, performed the procedures in Prague last week. Dr. Jacob Koruth of Mount Sinai Hospital joined Dr. Reddy and Prof. Neužil.

Pulsed field ablation is an innovative therapy that uses electric fields to treat heart tissue. PFA delivered by the Globe PF System is unique in that it achieves true single-shot isolation; a single application of the GlobePulse^™ Waveform achieves pulmonary vein isolation (PVI) in as little as 3 seconds. The Globe PF System also provides high-definition mapping:

• GPS^™ 3D Maps show the position of the Globe Catheter in the heart;
• CONTACT^™ Maps confirm tissue contact, ensuring precise treatment delivery; and
• Voltage and WAVE^™ Activation Maps confirm the effectiveness of the therapy.

“The Globe PF System is an exciting development in the treatment of AF,” said Dr. Reddy. “The unique design of the spherical Globe Catheter array, combined with the GlobePulse Waveform, allowed us to isolate the pulmonary veins in just 3 seconds per vein. We also observed that the PFA treatment was well-tolerated by the patients.”

“The Globe PF System is unique in that it combines mapping and ablation into a single catheter,” said Dr. Koruth. “We could navigate the Globe Catheter to the pulmonary veins, confirm contact with the tissue, and be confident that the therapy would be delivered where needed. After ablation, we could confirm isolation through detailed voltage maps and electrograms.”

“The Globe PF System represents a paradigm shift in pulsed field ablation,” said Kevin Chaplin, CEO, Kardium. “These procedures are an exciting step forward for Kardium. Now we prepare to start our US investigational device exemption (IDE) study with the Globe PF System next year.”

The Globe System is an all-in-one solution for treating the world’s most common heart rhythm disorder, atrial fibrillation, which affects an estimated 37 million people worldwide. The Globe Catheter has 122 electrodes that allow rapid, single-shot PVI, high-definition mapping, and atrial ablation. The Globe System, with RF ablation, received the CE Mark approval in June 2020 and is commercially available in Europe.

ABOUT KARDIUM

Kardium Inc. (kardium.com) is a rapidly growing medical solutions company that has developed an advanced system for atrial fibrillation (AF) treatment: the Globe Mapping and Ablation System. Kardium has built an outstanding team of engineers, medical researchers, compliance and production staff 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.