FDA clears Kardium Globe pulsed field ablation system
The U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) for the Globe Pulsed Field Ablation (PFA) System, along with 510(k) clearance for both the Globe introducer sheath and the Globe Pulsed Field System mapping software from Kardium. This adds another competitor to the growing U.S. PFA market for the treatment of atrial fibrillation (AFib).
The Globe system is the only integrated platform that combines high-density mapping and PFA in a single device. It features a 122-electrode spherical array designed to deliver rapid, effective, and durable single-shot pulmonary vein isolation (PVI), helping to streamline workflows.
“I am excited to have the Globe system available in the U.S.” Vivek Reddy, MD, director of cardiac arrhythmia service at Mount Sinai Fuster Heart Hospital, said in a statement. “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.”
The device saw impressive clinical data in its pivotal PULSAR clinical study of the Globe System was recently presented at the 2025 Heart Rhythm Society annual meeting. This data demonstrated remarkable results, with the system showing freedom from atrial arrhythmia at 1 year of 78% in paroxysmal AF patients, with 0% device-related primary safety events.
PFA systems are used for catheter ablation of AFib. PFA is considered safer than traditional radiofrequency and cryoablation technologies, which use heat or cold to destroy cardiac cells that generate abnormal arrhythmias. Instead, PFA creates electrical fields that induce electroporation, leading to controlled cell death. This approach reduces the risk of major complications, such as damage to the esophagus or surrounding nerves.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]