Johnson & Johnson Pauses US Varipulse Procedures Amid Safety Review, Investigates Brain-Related Events – Johnson & Johnson (NYSE:JNJ)

On Wednesday, Johnson & Johnson JNJ said it has temporarily paused all U.S. cases using its Varipulse pulsed field ablation (PFA) system.

Pulsed-field ablation (PFA) is a non-thermal procedure that uses high-amplitude electrical pulses to treat cardiac arrhythmias (irregular heartbeat) and tumors.

In November, the FDA approved the Varipulse Platform for drug-refractory paroxysmal Atrial Fibrillation (AFib).

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The VARIPULSE Platform is designed to enable AFib treatment with a single device that combines PFA therapy and advanced mapping with the CARTO 3 System, a 3D electroanatomical cardiac mapping system.

“On January 5, out of an abundance of caution, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and all U.S. Varipulse cases while we investigate the root cause of four reported neurovascular events in the U.S. External Evaluation,” the company said.

Neurovascular events are a range of conditions that affect the blood vessels and blood supply to the brain, spinal cord, and peripheral nerves.

Since the beginning of the external evaluation, the company has reported more than 130 cases of Varipulse in the U.S., spread across 14 sites and 40 operators. Globally, it has reported more than 3,000 commercial cases with Varipulse.

“We are working diligently to complete the investigation according to our medical safety processes and resume the U.S. External Evaluation,” the company said in its statement. “We expect to have more information to communicate within the coming days.”

Last month, the FDA issued a complete response letter (CRL) to Johnson & Johnson’s Biologics License Application for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration in patients with non-small cell lung cancer with epidermal growth factor receptor mutations.

The CRL is related to observations as part of a standard pre-approval inspection at a manufacturing facility.

Price Action: JNJ stock closed at $146.23 on Wednesday.

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