“Out of an abundance of caution, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and all U.S. Varipulse cases while we investigate the root cause of four reported neurovascular events in the U.S. External Evaluation,” the company said in a news release. “As the U.S. External Evaluation leveraged a unique platform configuration, there is no impact to commercial activity and Varipulse cases outside of the U.S.”
The Varipulse platform treats atrial fibrillation (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, which is adjustable from 25 mm to 35 mm. 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.
“We are working diligently to complete the investigation according to our medical safety processes and resume the U.S. External Evaluation. We expect to have more information to communicate within the coming days,” the company said.
The analysts’ take on the Johnson & Johnson MedTech Varipulse news
Needham analysts Michael Matson, David Saxon and Joseph Conway issued a report saying that an unnamed electrophysiologist confirmed that J&J “paused sales of its Varipulse PFA system due to reports of strokes with the device.”
They also 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.
“It is unclear how long the Varipulse sales will remain paused, but even if [Johnson & Johnson] 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. noting they expect Boston Scientific and Medtronic to benefit if their systems don’t have similar issues.
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.
The analysts said they believe Boston Scientific’s Farapulse “is largely proven at this point given the large number of real-world procedures and no indications to date of elevated stroke rates.”
“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.”
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