Biosense Webster, Inc., has announced European CE mark approval of the VARIPULSE™ Platform. The approval covers the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AF).
Background
AF is the most common type of cardiac arrhythmia, affecting over 11 million people in Europe. If left untreated, patients face a fivefold increased risk of stroke, while their risk of death doubles. Forecasts suggest that by 2030, prevalence will increase by up to 70 percent. As a result this presents an urgent need for innovative treatment solutions that deliver better outcomes for people living with AF.
Catheter ablation is a minimally invasive procedure performed by an electrophysiologist to treat heart rhythm disorders, including AF. It works to interrupt irregular electrical pathways in the heart by delivering either heat (radiofrequency ablation) or cold (cryoablation). PFA represents a new approach to treating AF. In fact it utilizes a controlled electric field to selectively ablate cardiac tissue that causes the irregular heartbeat. This process is called irreversible electroporation (IRE). Pulsed field energy is minimally thermal. As a result IRE offers the potential to reduce the risk of damage to surrounding tissues. These can include esophageal, pulmonary vein, and phrenic nerve injury.
Biosense Webster is a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech. We’ve covered news of the company’s VARIPULSE™ Platform before on our pages, here. The system comprises the VARIPULSE™ Catheter, a variable-loop multielectrode catheter; the TRUPULSE™ Generator, a multichannel PFA generator; and CARTO™M 3 System, the world’s leading 3D cardiac mapping system. Moreover the VARIPULSE™ Platform is the first and only CARTO – integrated PFA system. This means it delivers an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.
Clinical Trial of VARIPULSE™
The inspIRE trial investigated the safety and efficacy of the VARIPULSE™ Platform. This study included 186 patients in Canada and Europe. Investigators presented one-year follow-up data at the recent AF Symposium in Boston. Results demonstrated that among participants receiving optimal PFA applications, 80% achieved freedom from recurrence with zero primary adverse events. Furthermore, the primary effectiveness endpoint (PEE) of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AF, Atrial Tachycardia, or Atrial Flutter) was 75.6%. The study reported a low fluoroscopy time of 7.8 minutes. This was partly attributed to the integration of the VARIPULSET Catheter to the CARTO M 3 System. It also demonstrated a good safety profile with no (0.0%) primary adverse events reported.
Investigator comments
Tom De Potter,MD, Associate Director, Cardiovascular Center, OLV Hospital Aalst, Belgium comments. “CE mark approval of the VARIPULSE™ Platform represents a significant advance in catheter ablation technology. It allows electrophysiologists to offer patients in Europe pulsed field ablation treatment with real-time integrated 3D mapping.
“Significantly, the VARIPULSE™ Platform is fully integrated with the CARTO M 3 System. This enables a simplified workflow with minimal fluoroscopy time. Most importantly, the recent published data on the VARIPULSET Platform demonstrates the safety using pulsed field ablation for AF patients.”
Company comments
Jasmina Brooks, President, Biosense Webster comments. “At Biosense Webster, we continually seek to push the boundaries of science and technology innovation in cardiac ablation. CE mark approval of the VARIPULSE™ Platform is testament to this. It now offers healthcare professionals the potential to improve outcomes for people living with atrial fibrillation. Indeed it sets a new standard in cardiac electrophysiological mapping. We believe pulsed field ablation has the potential to offer safer, more consistent and efficient workflows. The VARIPULSE™ Platform uniquely offers physicians a simple and reproducible PFA workflow with 3D visualization, in real-time.”
The VARIPULSE™ Platform is not available for sale in the United States.
*The TRUPULSE™ Generator received CE Mark in Europe in December 2023.
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Source: PR Newswire
published: February 29, 2024 in: Approval/Clearance, Cardio, Clinical Studies/Trials, Johnson & Johnson, News