Johnson & Johnson Launches Omny-IRE Clinical Trial for Omnypulse PFA Ablation Catheter

Sep 25, 2023 00:00 CST Updated 00:00

Johnson & Johnson MedTech

Medical Device Manufacturer

Biosense Webster

Developer of Diagnostic and Therapeutic Devices for Arrhythmia

Source: Heart Future

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Heart Future

On September 18, 2023, Biosense Webster, a cardiac electrophysiology company under Johnson & Johnson MedTech, announced the launch of the Omny-IRE clinical study.The main purpose is to evaluateOmnypulseAblation Catheter andSafety and Effectiveness of the Trupulse Energy Platform.

# Omnypulse Ablation Catheter Completes First Surgery

As part of the study, the first procedure was completed using the investigational Omnypulse ablation catheter. The surgery was performed by Dr. Mattias Duytschaever at AZ Sint-Jan Hospital in Belgium.

Omny-IRE is a pivotal, prospective, multicenter, non-randomized trial expected to enroll approximately 135 patients. Conducted in Europe and Canada, the trial will evaluate the safety and efficacy of Omnypulse.

Dr. Duytschaever said, "In the cases I participated in for the Omny-IRE trial, the contact force data from the Omnypulse catheter helped create the initial electrogram in the Carto 3 system. The integrated PF index module allowed me to correlate ablation parameters with lesion formation. The system's versatility and potential for personalization are significant for patients."

The company stated that by using pulsed field ablation during the irreversible electroporation (IRE) process（PFA）, which can reduce the risk of damage to surrounding tissues, including esophageal, pulmonary vein, and phrenic nerve injuries.

Biosense Webster President Jasmina Brooks said that the company aims to achieve the best catheter ablation outcomes. Integrated electrocardiogram mapping and a multifunctional tool suite are "two key components" to achieving this goal.

# About Omnypulse Ablation Catheter

▲ Fig: Omnypulse Catheter

Omnypulse Is a product that canThe PFA ablation catheter integrated with Carto 3 has a distal expansion design, which can expand up to 12mm at maximum.Omnypulse Also designed with tactile feedback and enhanced mapping capabilities.OmnypulseCapable of interfacing with energy platformsTrupulseUsed in conjunction, providing bipolar biphasic pulse energy to the twelve electrodes on the Omnypulse catheter during cardiac ablation.The Omnypulse platform aims to treat atrial fibrillation through a single device that combines the ability to perform large-area ablation and create high-density electrocardiograms.

# About Biosense Webster

Biosense Webster, Inc., a subsidiary of Johnson & Johnson, is a professional medical device company dedicated to the research and development of electrophysiology interventional diagnosis and treatment products, providing comprehensive solutions for arrhythmia diseases to physicians and patients. With its excellent and innovative technology, Biosense has long been a world leader in 3D mapping systems and software. Currently, Biosense Webster, Inc. has more than 5,000 employees in over 50 countries worldwide and is also the inventor of the world's first deflectable catheter.

In 1996, Johnson & Johnson acquired Cordis and Biosense for $1.8 billion and $400 million respectively, officially entering the cardiac electrophysiology field. It then merged Cordis Webster with Biosense to form what later became the cardiac electrophysiology giant, Biosense Webster, Inc. Since then, Johnson & Johnson has continuously increased its investment through acquisitions, divestitures, channel support, and academic promotions, leveraging its global sales network to drive the development of its cardiac electrophysiology business. By 2015, Biosense Webster had captured 40% of the global cardiac electrophysiology market, establishing itself as a global leader in the field.

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