Johnson & Johnson’s Biosense Webster today announced the first cases with its investigational Omnypulse catheter as part of the Omny-IRE clinical trial.
The Omnypulse platform features the Omnypulse catheter and the Trupulse generator. Omny-IRE looks at the platform for mapping and treatment of symptomatic paroxysmal AFib during standard ablation procedures.
Dr. Dr. Mattias Duytschaever performed the first procedures at AZ Sint-Jan Hospital in Brugge, Belgium. Omny-IRE, a pivotal, prospective, multi-center, non-randomized trial looks set to enroll approximately 135 patients. Taking place in Europe and Canada, it will evaluate Omnypulse’s safety and effectiveness.
“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 Duytschaever. “I am excited about the potential for versatility and personalization of this system, and what this means for patients.”
More about the Biosense Webster Omnypulse platform
Biosense Webster designed the catheter as a large-tip, 12 mm device with Carto 3 system integration. It features contact force feedback and enhanced mapping capabilities.
The investigational Tripulse generator delivers a bipolar, biphasic pulse sequence to the catheter’s 12 electrodes during cardiac ablation. Biosense Webster said it designed the platform to enable AFib strategies with a single device. It combines a large ablation area with the ability to create high-density maps.
Using pulsed-field ablation through the irreversible electrocorporation (IRE) process, the company says it could reduce the risk of damage to surrounding tissues. That includes esophageal, pulmonary vein and phrenic nerve injury.
Biosense Webster President Jasmina Brooks said the company aims to enable the delivery of the best possible catheter ablation outcomes. Integrated mapping and a versatile portfolio of tools represent “two critical components” for this, she said.
“We are working to bring forward a diverse suite of best-in-class PFA tools – including loop, focal, and large focal catheters – designed to be fully integrated with our Carto 3 System to enable real-time catheter visualization with a low-fluoroscopy workflow,” Brooks explained.