J&J reports 12-month VARIPULSE real-world results and CE-mark update

Johnson & Johnson says new real-world data for its VARIPULSE platform showed favorable 12-month outcomes, while Europe also approved an update to the device’s instructions for use.

The company said the VARIPURE cohort included 1,023 patients across 22 European centers, with 442 patients completing 12-month follow-up at the time of analysis. J&J reported 84.2% freedom from documented atrial arrhythmia recurrence at 12 months, a 0.8% primary adverse event rate, and no reported strokes, coronary spasm or other pulsed-field-ablation-related complications.

J&J also said European regulators approved an IFU update for the VARIPULSE Catheter that allows ablation outside the pulmonary veins, based on real-world data and DEKRA approval.

The April 13 announcement follows an April 7 Europe launch of VARIPULSE Pro after CE Mark approval. J&J said the platform will be featured at EHRA 2026 alongside the VARIPURE data.

The company’s summary is based on interim results, and the broader significance of the IFU update may become clearer as additional clinical and regulatory details emerge.