Johnson & Johnson Resumes Varipulse PFA Rollout After Safety Review

Johnson & Johnson MedTech has resumed the U.S. rollout of its Varipulse PFA system after a temporary pause to review patient safety concerns. The company updated its instructions for use (IFU) to provide enhanced guidance, aiming to reduce the risk of neurovascular complications. Originally FDA-approved in 2024, the system demonstrated high procedural success in clinical trials, with minimal adverse events.

Johnson & Johnson Resumes Varipulse PFA Rollout After Safety Review

Johnson & Johnson MedTech has resumed the rollout of its Varipulse pulsed field ablation (PFA) system in the United States after temporarily pausing its use to evaluate reports of patient complications. The company announced that the system is performing as expected and that its effectiveness among U.S. patients is consistent with outcomes observed in other regions.

Biosense Webster, a division of Johnson & Johnson MedTech, presented updated findings on Varipulse at the AF Symposium 2024 in Boston. The decision to pause procedures using the device was initially made in early January after four cases of “neurovascular events” were reported among treated patients. However, the company did not disclose specific details about these complications. Following a thorough review, the phased market release of Varipulse has resumed.

As part of the reinstatement, Johnson & Johnson MedTech has updated the system’s instructions for use (IFU) to provide enhanced guidance for healthcare providers. The company noted that the likelihood of neurovascular complications may increase under specific circumstances, such as when multiple ablations are performed, ablations are stacked, or when ablations occur outside the pulmonary veins. To mitigate risks, the company is advising medical professionals to carefully adhere to the revised IFU and communicate the new information to patients.

In a statement, Johnson & Johnson MedTech emphasized its commitment to ensuring safety and educating healthcare providers on best practices. The company is actively engaging with professionals using Varipulse to reinforce adherence to the updated guidelines. Training and recommendations will continue to align with findings from clinical studies to optimize patient outcomes.

The Varipulse PFA system originally received FDA approval in November 2024, joining a growing list of PFA systems approved by the agency, including Medtronic’s PulseSelect and Affera systems, as well as Boston Scientific’s Farapulse system. The FDA’s approval was based on findings from the admIRE clinical trial, which evaluated the system’s performance in 277 patients across the United States.

The trial results demonstrated a 100% acute procedural success rate, with a primary effectiveness rate of 75%. Additionally, adverse events were reported in just 2.9% of participants, and 43% of patients were able to return home on the same day of their procedure. These outcomes underscored the potential benefits of the Varipulse system in treating patients with atrial fibrillation.

With the reintroduction of Varipulse, Johnson & Johnson MedTech remains focused on patient safety and the continued improvement of procedural protocols. By updating guidelines and enhancing physician education, the company aims to minimize risks while expanding access to the technology.

The company reaffirmed its dedication to monitoring patient outcomes and advancing the use of PFA technology for the treatment of atrial fibrillation. As more healthcare providers integrate Varipulse into their practices, Johnson & Johnson MedTech will continue to refine its recommendations and collaborate with the medical community to ensure optimal usage of the system.