Johnson & Johnson launches VARIPULSE Pro in Europe with CE Mark approval

Johnson & Johnson (NYSE: JNJ) announced the launch of VARIPULSE Pro in Europe following CE Mark approval. The device represents an advancement in the company's pulsed field ablation portfolio for treating cardiac arrhythmias.

VARIPULSE Pro features a pulse sequence that operates at lower temperatures and delivers ablation five times faster than the previous sequence while achieving equivalent lesions. The device integrates with the CARTO 3 System, which provides mapping capabilities and tissue proximity indicators for lesion delivery.

"In our early experience, VARIPULSE Pro has been exceptionally smooth and easy to use," said Tom De Potter, Head of Electrophysiology and Associate Director of the Heart Center at OLV Hospital in Aalst, Belgium. "The speed is particularly striking and contributes to more efficient procedures without compromising precision."

Initial cases are being performed under the VARIPURE multicenter, prospective, postmarket follow-up study. Johnson & Johnson stated it will conduct additional clinical studies during the commercial phase.

The company will demonstrate VARIPULSE Pro at the European Heart Rhythm Association annual meeting, including live case demonstrations and training sessions. Twelve-month interim results from the VARIPURE study will be presented at the EHRA PFA Summit.

Atrial fibrillation affects more than 50 million people worldwide and continues to grow in prevalence. VARIPULSE Pro is not currently approved in the United States.

The information is based on a company press release.

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