Johnson & Johnson MedTech announced that it intends to resume the rollout of its Varipulse platform in the U.S. after a temporary pause.
Last month, the medtech giant said it temporarily halted all U.S. cases using its Varipulse pulsed field ablation (PFA) system. It attributed the pause to an investigation of the root cause of four reported neurovascular events in a U.S. External Evaluation. A special configuration of the U.S. platform meant the issue did not extend to commercial Varipulse activity outside the U.S.
Analysts said the company “paused sales of its Varipulse PFA system due to reports of strokes with the device.” They cited a report of a stroke in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. That indicated that a patient experienced a stroke following Varipulse treatment. The analysts said at least two additional patients had strokes following Varipulse procedures in Europe.
Late Feb. 14, the company said it plans to resume its limited U.S. Varipulse rollout after an investigation “found the devices operate as intended.” Johnson & Johnson MedTech plans to update the Varipulse catheter’s instructions for use globally to include enhanced guidance.
The investigation looked at potential device-, procedure- and patient-related factors. It found no difference in performance of the available Varipulse configurations globally. The company said it found the potential for neurovascular events to increase as a result of the delivery of a high number of ablations, the stacking of ablations, and/or ablations outside of the pulmonary veins.
Johnson & Johnson MedTech said it continues communications with healthcare professionals to recommend they review and adhere to the updated instructions and share the information with patients.
“Varipulse is an important treatment option for patients with atrial fibrillation and remains available in all markets where commercially launched,” the company concluded.
FDA releases more details about the issues that led to the initial pause
In a Feb. 28 notice, the FDA outlined updated instructions for use released by Johnson & Johnson related to the Varipulse system. The instructions direct users to determine whether the balance of risk and benefits support using the device, considering the patient’s individual situation, with the known and inherent risk of neurovascular events.
Johnson & Johnson updated the instructions due to a high rate of stroke or transient ischemic attack (TIA or “mini stroke), the FDA said. These risks were seen in the first 132 procedures after FDA approval in November 2024. The FDA said the company limited its distribution to a few U.S. hospitals to get more feedback.
Of the 132 patients treated during this limited evaluation, four patients (approximately 3%) had a stroke or mini stroke shortly after surgery. This exceeded the frequency expected for this type of surgery (typically 1% or less) according to the FDA.
The company investigated the surgeries that resulted in these events and found some differences between how the device was used and the recommendations in the use instructions. These differences could explain the higher risk of stroke or mini stroke and include treatment of patients with a more advanced form of irregular heart rhythm, more energy deliveries to the heart, repeated energy deliveries to the same location in the heart, and energy deliveries to locations not studied in clinical trials.
Based on the available data that may link these differences to stroke or mini stroke,the compay recommends using the device only as studied, which is reflected in the updated use instructions.
Johnson & Johnson also plans to cunduct U.S. Post-Approval Study. This will further investigate the benefits and risks associated with the use of the Varipulse ablation catheter for the treatment of paroxysmal atrial fibrillation.
More about the Johnson & Johnson MedTech Varipulse system
The Varipulse platform treats AFib with a single device that combines PFA with the Carto 3 mapping system. Its variable-loop, multi-electrode Varipulse catheter uses laser-cut nitinol tubing for its loop shape. The platform also includes TruPulse generator and the Carto 3 3D cardiac mapping system.
J&J joined Medtronic and Boston Scientific as companies with PFA technologies approved for treating AFib when it received an FDA nod in November.
The company reported more than 130 cases with Varipulse in the U.S. since it began external evaluation. Those took place across 14 sites and 40 operators. Globally, it reported more than 3,000 commercial cases with Varipulse.
Medtronic’s PulseSelect PFA system became the first to win FDA approval for AFib in 2023. Boston Scientific followed with its Farapulse system in January. Medtronic added to its offerings in October with an FDA nod for its Affera mapping and ablation system with the Sphere-9 catheter.
At the time of the Varipulse pause, analysts said they expected Boston Scientific and Medtronic to benefit if their systems don’t have similar issues.
“This news makes us more positive on [Boston Scientific] since our recent downgrade mainly centered on the competitive risk posed by both the [Medtronic] and [Johnson & Johnson] PFA product launches.”
They also suggested potential issues even when Varipulse sales resume.
“It is unclear how long the Varipulse sales will remain paused, but even if JNJ allows sales to be resumed, we believe that the product is now likely to be tainted and that electrophysiologists are likely to be wary of using it,” the analysts wrote.
