J&J’s Varipulse returns to US market with updated guidance

USA—American multinational Johnson & Johnson has resumed the limited market release of the Varipulse heart device in the United States following a detailed investigation that confirmed it is working as intended.

 This news comes after the company temporarily halted the device’s use in January due to concerns raised by four reported stroke events.

The Varipulse device, which employs an innovative pulsed field ablation technique to treat certain abnormal heart rhythm conditions, such as atrial fibrillation, received approval from the U.S. Food and Drug Administration last year.

When the pause was implemented as a precautionary measure, the device had already been used in more than 130 cases in the U.S.

 All ongoing external evaluation cases were halted during this suspension, and the introduction of new cases was temporarily stopped.

After conducting an in-depth investigation, Johnson & Johnson confirmed that the Varipulse devices function as expected, with no differences in performance observed between the various configurations used globally.

However, the investigation did reveal a vital safety consideration: the risk of neurovascular events could increase when a high number of ablations are performed, when ablations are stacked, or when ablations are performed outside the pulmonary veins.

In light of these findings, the company has updated the Instructions for Use (IFU) for the VARIPULSE™ Catheter globally to include enhanced guidance.

To ensure the highest standards of patient safety, Johnson & Johnson is actively communicating with healthcare professionals who use the VARIPULSE™ device.

The updated IFU is being shared widely, and professionals are encouraged to review the new guidelines and discuss them with their patients.

This proactive approach aims to help clinicians align their practices with the most current recommendations derived from clinical studies, thereby reducing any potential risks associated with the treatment.

Despite the earlier suspension, the Varipulse device remains a crucial treatment option for patients with atrial fibrillation.

Its successful global rollout, with over 3,000 commercial cases completed, underscores its importance in the medical field.

By resuming the limited release in the United States, Johnson & Johnson demonstrates its commitment to balancing innovation with rigorous safety standards.

The company plans to continue educating healthcare providers and ensuring that the latest clinical insights are reflected in everyday medical practice, ultimately enhancing the quality of care provided to patients.

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