Kardium has completed enrolment in a study evaluating its pulsed-field ablation (PFA) device for the treatment of atrial fibrillation.
According to a ClinicalTrials.gov entry, the PULSAR trial (NCT05462145) is estimated to enrol 449 participants with the heart condition.
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Kardium’s device is called the Globe System – a 122 gold electrode catheter that delivers pulsed field energy to the heart. Pulsed-field ablation is an emerging promising technology that uses electric field energy to destroy diseased heart tissue while keeping neighbouring structures intact. Traditional methods frequently use thermal energy, which can sometimes damage local tissue.
Canada-based Kardium says its catheter electrodes can map the patient’s cardiac anatomy and electrical activity. The energy can be precisely targeted to the area of interest, according to the study’s co-principal investigator, Dr Atul Verma.
The PULSAR study, operating under an investigational device exemption (IDE) by the US Food and Drug Administration (FDA), will assess efficacy in patients a year after a treatment procedure with the Globe system. Primary outcomes will include the number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia. Safety will be measured within a week of the procedure.
Data from the study will be used to support a pre-market approval (PMA) application to the FDA.
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By GlobalDataKardium’s CEO Kevin Chaplin said: “We are committed to working closely with the FDA during the PMA submission process to bring this state-of-the-art technology to the market.”
Medtronic received FDA approval for its PulseSelect system to become the first pulsed-field ablation catheter approved in the US in December 2023. Boston Scientific gained US approval for its Farapulse system earlier this year. Both Medtronic’s PulseSelect and Biosense Webster’s are also approved in Europe to treat atrial fibrillation.
A report by GlobalData estimates the global ablation catheter market will grow to $3.8bn in 2033, up from $2.5bn in 2023. The market model places Biosense Webster, Abbott and Medtronic as market leaders.
