Johnson & Johnson Halts Varipulse Pulsed-Field Ablation Cases in the US

Johnson & Johnson Medtech has temporarily paused all Varipulse pulsed-field ablation (PFA) cases in the United States after four neurovascular events were reported during an external evaluation study.

The pause, initiated out of caution, allows the company to investigate the root cause of these complications.

The system used in the US evaluation involved a unique platform configuration, so the pause does not affect Varipulse commercial activity outside the US, where over 3,000 cases have been successfully completed.

This setback follows FDA approval for Varipulse in November 2024, supported by the admIRE trial, which had previously raised concerns about stroke and transient ischemic attack (TIA) risks.

Some physicians, like Sumit Verma, view the pause as a hindrance to broader PFA adoption, potentially pushing centers to explore alternative systems.

Others, like Jonathan Piccini, believe the pause highlights how much is still unknown about the safe and effective delivery of PFA technology.

Speculation around the reported neurovascular events includes possible causes such as:

• Air emboli or gas bubbles generated by high-voltage electrical currents during procedures.
• Clots formed during transseptal procedures.
• Heat-induced embolic particles from tissue ablation.

Experts agree that these issues could stem from initial challenges in managing large-profile catheters and procedural workflows.

Despite these concerns, many operators involved in the US evaluation reported no neurovascular issues in their centers.

Globally, the Varipulse system has shown promise, with more than 130 cases performed by 40 operators across 14 US sites as part of the external evaluation.

Physicians like Dhanunjaya Lakkireddy believe the complications are manageable and expect to resume using Varipulse once the investigation concludes.

The situation underscores the need for continued learning and refinement of PFA technology, even as it remains a promising treatment for conditions like paroxysmal atrial fibrillation.

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Take-Home Points:

• Johnson & Johnson has paused US Varipulse PFA cases to investigate neurovascular events reported in an external evaluation study.
• The pause does not affect commercial activities outside the US, where over 3,000 cases have been completed.
• Potential causes of complications include air emboli, clots, and heat- or current-induced embolic particles.
• Physicians emphasize that effective workflow and catheter management are critical to minimizing risks.
• The pause reflects the importance of refining PFA technology and addressing safety concerns as its use expands.