J&J launches latest version of its pulsed ablation device after nabbing CE Mark

J&J Medtech has launched the latest version of its pulsed ablation device after receiving CE Mark approval in Europe.

The Varipulse Pro is touted by the company as improving the process of the procedure as well as bolstering its safety, the company said in an April 7 press release.

Traditional ablations use thermal energy that may cause unintended damage to nearby organs and tissues, whereas pulsed field ablation relies on quick bursts of electric fields to permanently disrupt the membranes of cardiac muscle cells that can drive arrhythmias.

The latest version of the Varipulse system uses a pulse sequence with a lower temperature profile and an ablation that is five times faster than the previous sequence.

“The introduction of Varipulse Pro in Europe reflects our commitment to advancing our PFA platforms through continuous innovation, enhancing procedural experience while maintaining the consistency and precision physicians expect from the Varipulse Platform,” Michael Bodner, a J&J Medtech group chair, said in the release.

The company is expected to release 12-month interim results from its ongoing Varipure study evaluating pulsed field ablation with the Varipulse platform next week in Paris at the European Heart Rhythm Association's annual meeting. The Varipulse Pro is not currently approved for use in the U.S.

J&J received an FDA approval for its separate Varipulse system in November 2024, following green lights in Europe and Japan. Its initial U.S. rollout was paused in January 2025 following reports of four strokes among early patients, however, commercial efforts restarted in February, with the company recommending that clinicians avoid stacking repeated ablations in the same tissue.