Biosense Webster, part of the Johnson & Johnson Medical Devices Companies, has announced the presentation of data from the inspIRE clinical trial at the European Society of Cardiology’s 2021 congress (ESC 2021, 27–30 August, virtual).
inspIRE is a prospective, multicentre, non-randomised study evaluating the safety and effectiveness of the investigational Varipulse catheter and Trupulse generator, which uses pulsed field ablation (PFA) in treating symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation (AF), with planned enrolment of up to 550 patients.
Initial results of 35 subjects were presented by Tom de Potter, associate director, Cardiovascular Center Department of Cardiology, Electrophysiology Section at OLV Hospital, Aalst, Belgium.
The data show acute procedural success (pulmonary vein isolation [PVI]) was achieved in 100% of these study subjects with no procedural adverse events. Additionally, the findings agree with prior observations of the tissue-selectiveness of PFA in preclinical studies and the study exhibited low procedure time of 82.4±20 minutes. The pivotal phase of the study will continue to evaluate the 12-month safety and effectiveness.
“Pulsed field ablation marks a new era of treating atrial fibrillation for electrophysiologists. These positive results are exciting as we continue to evaluate the safety and efficacy of PFA and bring this new approach forward,” said de Potter. “I am encouraged by this data and looking forward to seeing continued results so that we can help bring safer, more efficient treatments to our atrial fibrillation patients.”
PFA represents an emerging approach to treating atrial fibrillation. This technique utilises a controlled electric field to ablate and scar cardiac tissue through a process called irreversible electroporation (IRE). As it does not rely on thermal effects to ablate target cardiac tissue, IRE offers the potential to reduce the risk of esophageal, pulmonary vein and phrenic nerve injury. The investigational Varipulse catheter is a steerable, multi-electrode, catheter enabling cardiac electrophysiological mapping (stimulating and recording) and ablation functionalities through the investigational Trupulse generator.
“These promising inspIRE study results mark an important first step in evaluating the potential of this novel treatment option to patients suffering from cardiac arrhythmias,” said Uri Yaron, worldwide president, Biosense Webster. “We are committed to the electrophysiology community and transforming the types of treatments they can offer patients. We look forward to seeing additional results as this trial continues.”
In September 2020, Biosense Webster announced that it had enrolled and treated the first patients in the inspIRE clinical study in Europe, evaluating safety and effectiveness of the Varipulse catheter and Trupulse Generator. Varipulse catheter is an investigational technology and is not approved by regulatory bodies in any market today.