Johnson & Johnson (NYSE:JNJ) said it has launched the VARIPULSE Pro system in Europe after receiving CE Mark approval. The device expands the company’s pulsed field ablation (PFA) offerings used in the treatment of cardiac arrhythmias.
VARIPULSE Pro incorporates a pulse sequence designed to operate at lower temperatures while delivering ablation up to five times faster than the previous sequence, while still producing comparable lesions. The system is integrated with the CARTO 3 platform, which provides advanced mapping capabilities and indicators to guide precise lesion placement.
“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.”
The first procedures using the device are being conducted as part of the VARIPURE multicenter, prospective postmarket follow-up study. Johnson & Johnson said additional clinical studies will be carried out as the device moves through its commercial rollout phase.
The company also plans to showcase VARIPULSE Pro at the upcoming European Heart Rhythm Association annual meeting, where live case demonstrations and training sessions will be held. Interim 12-month data from the VARIPURE study will also be presented during the EHRA PFA Summit.
Atrial fibrillation affects more than 50 million people globally and its prevalence continues to rise. VARIPULSE Pro has not yet received regulatory approval in the United States.