Johnson & Johnson launches advanced Varipulse Pro Ablation System in Europe with CE Mark approval

UK—Johnson & Johnson has officially introduced Varipulse Pro to European markets following its CE Mark approval, a major boost of the company’s pulsed field ablation (PFA) capabilities.

The new system delivers substantial improvements over its predecessor, featuring an innovative pulse sequence that operates at lower temperatures while accelerating ablation procedures by five times faster than previous generations.

The Varipulse Pro platform seamlessly connects to the Carto 3 System, leveraging sophisticated mapping technology and tissue-proximity sensors to ensure accurate lesion placement during cardiac procedures.

This integration enhances procedural precision, allowing physicians to perform complex ablations with greater confidence and consistency.

Clinical evidence and market rollout strategy

The company has already started enrolling patients in the VARIPURE multi-centre study, a prospective postmarket investigation designed to establish robust clinical evidence as the device becomes commercially available.

This structured approach demonstrates J&J’s commitment to generating real-world data alongside conventional clinical research throughout the launch phase.

Michael Bodner, chair of J&J MedTech’s electrophysiology and neurovascular division, emphasized that Varipulse Pro represents the company’s dedication to advancing PFA technologies through continuous refinement.

He noted that the platform maintains the reliability and precision physicians have come to expect while building on learnings from clinical practice and scientific research.

By combining real-world feedback with technological innovation, the company aims to support medical professionals in delivering superior patient care outcomes.

European showcase and clinical presentation

Varipulse Pro will receive prominent visibility at the European Heart Rhythm Association (EHRA) annual meeting, where J&J plans to conduct live procedure demonstrations and offer practical training sessions for healthcare professionals.

These educational initiatives will provide clinicians with hands-on experience using the new system.

During the event, Dr. Daniel Scherr, who contributed to the VARIPURE trial as both a study investigator and J&J consultant, will present interim data from the 12-month follow-up period at the EHRA PFA Summit.

His presentation will highlight early outcomes from patients enrolled in the ongoing trial.

The Varipulse Pro remains unavailable in the United States market at this time.

Recent FDA approval expands J&J’s ophthalmology portfolio

In related news, J&J recently secured FDA clearance for the TECNIS PureSee extended depth of focus intraocular lens, a specialized device developed for cataract surgery applications.

This lens technology expands the company’s ophthalmology offerings and addresses a key clinical need in vision correction.

The TECNIS PureSee IOL is anticipated to reach American patients by year’s end, pending final manufacturing and distribution preparations.