Johnson & Johnson MedTech (NYSE: JNJ) announced a provisional halt to U.S. Varipulse cases and evaluations. The company decided to pause activities on January 5th, driven by an extreme precautionary approach, after identifying four neurovascular incidents in the U.S. evaluations. The company stated that this pause does not affect international Varipulse procedures, which continue as usual.
The Varipulse technology utilizes pulsed field ablation (PFA) to address AFib, integrating it with the Carto 3 mapping system. This system employs a customizable multielectrode catheter, featuring a laser-cut nitinol loop adjustable from 25 to 35 mm. The platform includes the TruPulse generator alongside the Carto 3 3D cardiac mapping solution.
Johnson & Johnson entered the PFA market joining Medtronic and Boston Scientific, receiving FDA approval in November for treating AFib with its technology. Since beginning evaluations in the U.S., over 130 cases across 14 sites and 40 operators have been conducted, while globally more than 3,000 commercial procedures had been completed.
In a statement, Johnson & Johnson MedTech highlighted their commitment to addressing this matter: “We are moving quickly to conclude our investigation per our medical safety protocols in order to resume U.S. examinations shortly. We will disclose further findings soon.”
Analyst Perspectives on the Recent Developments
Analysts Michael Matson, David Saxon, and Joseph Conway from Needham issued insights regarding the situation, corroborating reports of Varipulse sales suspension following stroke allegations. A stroke incident linked to Varipulse was noted in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Additionally, at least two European cases were identified where patients experienced strokes after Varipulse treatments.
The analysts remain uncertain about the duration of sales suspension and speculate that even if resumed, Varipulse might face challenges regaining user trust amid its competitors, specifically Boston Scientific and Medtronic.
Medtronic’s PulseSelect PFA system first secured FDA approval for AFib treatment, followed by Boston Scientific’s Farapulse approval this January. Medtronic recently expanded its offering with another FDA clearance for its Affera mapping and the Sphere-9 catheter.
“We trust Boston Scientific’s Farapulse, given no notable rise in stroke cases post-treatments and substantial real-world usage,” the analysts remarked. “These developments incline us favorably towards Boston Scientific, particularly after our recent downgrade focused on the competitive threat from PDT and JNJ’s PFA innovations.”