Kardium Reports 1st Commercial Procedures with Globe PFA

Kardium announced successful completion of the first commercial procedures using its Globe pulsed field system, an integrated mapping and ablation system to treat atrial fibrillation (AFib).

The Globe system combines high-density mapping and ablation into a single catheter. This allows to delivery precise, targeted ablation using thermal contact assessment and tailed electrode selection—allowing for single-shot pulmonary vein isolation and other customizable lesion sets.

The inaugural U.S. procedures were performed by Dr. Devi Nair, Chief of Cardiac Electrophysiology and EP Research at St. Bernards Medical Center in Jonesboro, Arkansas.

“We are very excited to offer our patients access to this groundbreaking new technology,” said Dr. Nair. “The Globe Pulsed Field System gives me greater confidence that each lesion is delivered safely and effectively, to support better outcomes for my patients while also simplifying the procedure.”

The company earned U.S. Food and Drug Administration (FDA) approval for its Globe introducer sheath and pulsed field system mapping software last month.

Data from Kardium’s pivotal PULSAR study, presented at this year’s Heart Rhythm Society annual meeting, showed 78% freedom from atrial arrhythmia in paroxysmal AFib patients. There were no device-related primary safety events and 95% lesion durability, as well.

“These first commercial procedures with the Globe System signal the beginning of a new era in AF treatment,” said Kevin Chaplin, CEO of Kardium. “We are proud to partner with leading physicians like Dr. Nair to bring the Globe Pulsed Field System into clinical practice allowing us to deliver a more personalized treatment for atrial fibrillation to improve long-term outcomes for patients.”