Canadian medical device firm Kardium has received pre-market approval (PMA) from the US Food and Drug Administration (FDA) for its Globe Pulsed Field System.
The FDA also granted 510(k) clearance for the Globe Pulsed Field System mapping software, alongside the Globe Introducer sheath.
The Globe Pulsed Field System is designed to enhance treatment for atrial fibrillation (AF) by enabling single-shot pulmonary vein isolation (PVI) with a single catheter.
It integrates advanced cardiac mapping and ablation technologies, including Globe Catheter, Globe Introducer, Globe Mapping Software, and Globe PF Generator.
Also, it features a 122-electrode spherical array for rapid PVI, real-time thermal contact sensing, and dense electrode coverage for creating precise lesions.
The Globe platform aims to streamline workflows and improve treatment outcomes for atrial fibrillation patients, said Kardium.
Kardium CEO Kevin Chaplin said: “The FDA approval of the Globe System represents the most significant milestone in the life of Kardium.
“We are extremely proud of the achievements of the team to deliver on our mission of developing the best treatment for AF. The Globe System supports a personalised, efficient, and effective AF treatment.”
Clinical data from the PULSAR study, presented at the 2025 Heart Rhythm Society meeting, validated the effectiveness of the Globe Pulsed Field System.
The study involved 183 patients with paroxysmal atrial fibrillation across 12 centres in the US, Europe, and Canada.
Results indicated a 78% freedom from atrial arrhythmia after one year.
Other key findings included zero device-related primary safety events, 100% acute procedural success, and 25 minutes average time to isolate all pulmonary veins.
Mount Sinai Fuster Heart Hospital, New York, cardiac arrhythmia services director Vivek Reddy said: “I am excited to have the Globe System available in the US.
“The ability of the Globe System to achieve highly durable lesions with an excellent safety profile, together with integrated high-density mapping and true single-shot PVI, offers a distinctive and comprehensive approach to the treatment for atrial fibrillation.”
In July this year, Kardium secured $250m in a financing round to support the commercial launch of the Globe System.
