Kardium has unveiled further results from the pivotal trial of its Globe Pulsed Field System, demonstrating the system’s success in pulmonary vein isolation (PVI) and paroxysmal atrial fibrillation (AFib) treatment.
In the Canadian company’s PULSAR pivotal trial (NCT05462145) in patients with abnormal heart rhythms, which was operated under an investigational device (IDE) exemption from the US Food and Drug Administration (FDA), Globe achieved durable PVI in 95% of veins following a single pulsed field application.
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Kardium already released key findings from the trial in April 2025. At 12 months in the study, 78% of patients remained free from atrial arrhythmias, a result Kardium said ‘further underscored’ the system’s efficacy in treating drug-refractory paroxysmal AFib.
Throughout the study, no device-related primary safety events were observed. The study’s results were published in the Journal of the American College of Cardiology (JACC) on 21 January.
Globe is comprised of a single catheter, equipped with a 122-electrode array and associated software. According to Kardium, Globe is the only system that enables single-shot PVI and targeted ablation using a single catheter.
Dr Vivek Reddy, principal investigator of the PULSAR trial, said the results highlight Globe’s potential to advance how AFib is treated.
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By GlobalDataResearch indicates that AFib, a type of heart rhythm disorder that can increase the risk of stroke and potentially lead to heart failure due to the formation of blood clots in the atria, could affect up to 50 million people in the US by 2050.
Reddy continued: “These results show that this technology can make a real difference for patients, offering them better outcomes and a safer path to long-term relief from arrhythmias.”
Kardium CEO Kevin Chaplin said the PULSAR trial results served as a “tremendous validation” of Globe’s safety and efficacy.
“We are committed to delivering the most advanced system for the treatment of atrial fibrillation,” Chaplin added.
While Globe received a CE mark in Europe in 2020, Kardium’s system is a newer entrant into the rapidly advancing PFA space in the US. Globe received pre-market approval (PMA) and 510(k) clearance for the system’s introducer sheath and the mapping software from the FDA in September 2025.
In October 2025, Kardium completed the first commercial procedures with Globe in the US and stated that it is partnering with leading electrophysiology centres to expand the system’s availability.
In June 2025, the company raised $250m to help expand manufacturing facilities and production capacities for the device.
GlobalData analysis reveals that the PFA market, a sub-segment of the electrophysiology devices market, is growing at a CAGR of 11.2% and projected to reach a valuation of over $23bn in 2034.
According to a GlobalData market model, in 2025, Johnson & Johnson (J&J) held a 43.1% share of the US electrophysiology ablation catheter market, ahead of Boston Scientific and Medtronic in second and third position with market shares of 25.6% and 24.6%. However, with Boston outlining its intention to expand indications to other arrythmias, including ventricular tachycardia, GlobalData currently places Boston as the US market leader for PFA devices.
Speaking at the J.P. Morgan Healthcare Conference, which took place between 12-15 January in San Francisco, Boston’s CEO Mike Mahoney also said that the company plans to expand into ambulatory surgical centres, citing this area as another unaddressed market in which PFA can be used.
