FDA Approves Kardium’s Globe Pulsed Field Ablation System

Kardium has received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its Globe pulsed field system and 510(k) clearance for the Globe introducer sheath and Globe pulsed field system mapping software.

According to the company, the Globe system is the only integrated, high-density cardiac mapping and ablation system that allows single-shot pulmonary vein isolation (PVI) and customizable, targeted ablation using a single catheter. The platform was engineered to improve outcomes, streamline workflows, and expand treatment options for atrial fibrillation (AFib) patients.

The fully integrating cardiac mapping and ablation platform introduces the Globe catheter, Globe introducer, Globe mapping software, and Globe PF generator. It delivers tailored, tissue-specific therapy, combining high-density mapping and pulsed field ablation (PFA) in a single device.

Its 122-electrode spherical array allows for quick, effective, and durable PVI, Kardium said. The platform touts real-time thermal contact sensing, dense electrode coverage for precise lesion creation, and advanced visualization tools to guide ablation strategy and confirm treatment success.

Dr. Vivek Reddy of The Mount Sinai Fuster Heart Hospital, New York, said he is excited to have the Globe system available in the U.S.

“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,” Dr. Reddy told the press.

Clinical data from the Globe system’s pivotal PULSAR study was presented at this year’s Heart Rhythm Society annual meeting. The data showed freedom from atrial arrhythmia at one year of 78% in paroxysmal AFib patients, with no device-related primary safety events.

“The FDA approval of the Globe System represents the most significant milestone in the life of Kardium.” said Kevin Chaplin, CEO 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 personalized, efficient, and effective AF treatment.”

Earlier this summer, the company secured $250 million in new funding to help finance the premiere of the Globe pulsed field system.

Dive deeper into pulsed field ablation (PFA) technology here!