Positive One-Year Efficacy Results Released for Kardium’s Globe PF System

Kardium Inc. is sharing encouraging one-year clinical trial results for its pulsed field ablation (PFA) device—the Globe PF System, which is currently under Pre-Market Approval review with the U.S. Food and Drug Administration.

Key results included:

• No device-related primary safety events
• 78% 12-month primary effectiveness
• 100% acute procedural success
• A 25-minute average time to isolate all pulmonary veins
• 1.2 PFA applications per vein on average

“These one‑year efficacy results underscore the advanced catheter design of the Globe PF System,” said Dr. Vivek Reddy, co-principal study investigator from The Mount Sinai Fuster Heart Hospital, New York, N.Y. “Given the excellent durability achieved by the Globe PF System, the efficacy result is likely approaching the limit of what we can achieve with PV isolation alone.”

With just 1.2 applications per vein, the Globe PF System is billed as the true single-shot PFA solution with integrated mapping and ablation built into a single catheter.

“We are very pleased with the study’s safety results,” stated Dr. Atul Verma, co-principal study investigator from McGill University Health Centre in Montreal. “The Globe PF System has demonstrated an exceptional safety profile and offers many key safety differentiators. Its unique design provides single-shot energy application with precise ablation control that allows us to make individualized patient‑centered treatment decisions.”

The PULSAR IDE trial is a global, prospective, multicenter, single-arm study to demonstrate the Globe PF System’s safety and long-term efficacy. The trial enrolled 183 patients across 12 centers in the United States, Europe, and Canada with symptomatic paroxysmal atrial fibrillation. The data¹ is preliminary, however; the full results will be included in a future publication.

“These are truly outstanding results from the PULSAR IDE study,” Kardium CEO Kevin Chaplin commented. “The Globe PF System achieved incredible results for safety, efficacy, durability, PFA applications and procedure times. This study is another big step towards achieving our mission at Kardium of delivering the best treatment for atrial fibrillation.”

Atrial fibrillation is the most common type of cardiac arrhythmia, affecting more than 8 million people in the United States and nearly 50 million people worldwide.² Unlike other catheter ablation systems, the Globe PF System is the only solution of its kind to combine single-shot PV isolation, advanced mapping and atrial ablation into a single catheter.

Kardium is a privately held medical solutions company comprised of scientists, engineers, creatives, and business professionals striving to deliver the best treatment for atrial fibrillation.

References
¹ A Multielectrode Spherical Array Pulsed Field Ablation System to Treat Paroxysmal Atrial Fibrillation: 1-Year Outcomes of the PULSAR IDE Trial. Oral presentation at HRS 2025 by Dr. Vivek Reddy (New York, USA).
² Kornej J, Benjamin EJ, Magnani JW. Atrial fibrillation: global burdens and global opportunities. Heart 2021;107:516-518.