Canada-based Kardium has revealed positive one-year efficacy results on its pulsed field ablation (PFA) device, the Globe PF system, at the Heart Rhythm Society (HRS) meeting in San Diego, US, from 24 to 27 April.
The company’s device comes in the form of a catheter equipped with 122 electrodes to map the heart’s electrical activity and deliver pulsed energy to the heart to treat atrial fibrillation (AFib). In June 2024, the company closed a $104m fund raise to help the company complete clinical activities.
PFA involves the delivery of pulsed electric field energy to disrupt and destroy cardiac tissue that causes AFib while keeping nearby structures intact. Research indicates that the condition, which can increase the risk of stroke due to the formation of blood clots in the atria, could affect up to 50 million people in the US by 2050.
Kardium’s prospective, single-arm PULSAR study (NCT05462145) enrolled 183 patients with AFib across sites in the US, Canada, and Europe. Operated under an investigational device exemption (IDE) from the US Food and Drug Administration (FDA), the Globe system achieved primary effectiveness of 78% over the 12 months, 100% acute procedural success, an average pulmonary vein isolation time of 25 minutes, and an average of 1.2 PFA applications per vein. No device-related primary safety events were reported.
Dr Atul Verma, cardiologist and cardiac electrophysiologist at McGill University Health Centre and co-principal investigator on the study, commented: “We are very pleased with the study’s safety results.
“The Globe PF System has demonstrated an exceptional safety profile and offers many key safety differentiators. Its unique design provides single-shot energy application with precise ablation control that allows us to make individualised patient‑centred treatment decisions.”
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By GlobalDataGlobe PF is currently under premarket approval (PMA) review at the FDA. Kardium CEO Kevin Chaplin called the study results “truly outstanding”. The company noted that the results presented at HRS were preliminary and that the study’s full data will be shared in a publication at a later date.
The PFA field is ramping up at pace. According to GlobalData analysis, the market hit revenues of over $500m last year, with the FDA’s approval of Boston Scientific’s Farapulse PFA system in January 2024, following the agency’s approval of Medtronic’s PulseSelect PFA system in December 2023.
Others eyeing entry into the space following Boston Scientific and Medtronic, whose devices represent the first PFA systems for AFib approved by the FDA. Another market entrant is Pulse Biosciences, which launched a first-in-human study of its CellFX nanosecond PFA (nsPFA) technology in 2024 and plans to initiate a pivotal trial of the system this year.
