Evaluation begins of large-tip focal pulsed field Omnypulse catheter in Omny-IRE clinical trial in Europe

The first procedures were performed by Dr. Mattias Duytschaever at AZ Sint-Jan Hospital in Brugge, Belgium.

The Omny-IRE clinical trial is a pivotal, prospective, multi-center, non-randomized study that will enroll approximately 135 patients in Europe and Canada to evaluate the safety and effectiveness of the Biosense Webster Omnypulse Platform, the principal components of which are the Omnypulse Catheter and the Trupulse Generator. The study will evaluate the platform for the mapping and treatment of symptomatic paroxysmal atrial fibrillation (AFib) during standard ablation procedures.

“In the cases I performed as part of the Omny-IRE trial, the contact force data from the Omnypulse Catheter aided the initial map creation in the Carto 3 System, and the integrated PF Index module allowed me to correlate my ablation parameters with the lesion creation,” said Mattias Duytschaever M.D., Ph.D., Department of Cardiology, Electrophysiology Section, AZ Sint-Jan Hospital, Brugge, Belgium. “I am excited about the potential for versatility and personalization of this system, and what this means for patients.”

Catheter ablation is a minimally-invasive procedure performed by an electrophysiologist to treat heart rhythm disorders, including AFib, by interrupting irregular electrical pathways in the heart by delivering either heat (Radiofrequency ablation) or cold (Cryoablation). PFA represents a new approach to treating AFib, utilizing a controlled electric field to selectively ablate cardiac tissue that causes the irregular heart beat through a process called irreversible electroporation (IRE). Because the pulsed field energy is minimally thermal, IRE offers the potential to reduce the risk of damage to surrounding tissues including esophageal, pulmonary vein, and phrenic nerve injury.

AFib is the most common type of cardiac arrhythmia and impacts nearly 37.5 million people worldwide, and 11 million people in Europe alone. Today, about 1 in 4 adults over the age of 40 are at risk for developing AFib. Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options and the importance of early treatment to avoid risk of stroke and disease progression.

“Mapping integration is critical in the treatment of AFib, especially with pulsed field energy, in order to provide immediate feedback on patient anatomy and appropriate treatment location. The ability to make optimal, patient-tailored treatment decisions with the help of an integrated solution that allows us to both evaluate and treat is of tremendous value to the EP community,” added Dr. Duytschaever. “I’m eager to expand our knowledge in the rapidly advancing field of PFA with the Omny-IRE trial.”

The investigational Omnypulse Catheter is a large-tip, 12 mm catheter with Carto 3 System integration that is designed with contact force feedback and enhanced mapping capabilities. The investigational Trupulse Generator provides a bipolar, biphasic pulse sequence to the catheter’s twelve electrodes during cardiac ablation. The Omnypulse Platform is designed to enable AFib treatment strategies with a single device that combines a large ablation area with the ability to create high-density maps.