J&J pauses US rollout of Varipulse heart device

J&J pauses US rollout of Varipulse heart device after stroke reports
(Reuters) -Johnson & Johnson said on Wednesday it had temporarily paused the rollout of its Varipulse heart device in the United States, as the company investigates four reported stroke events. The Manufacturer and User Facility Device Experience (MAUDE),
Johnson & Johnson MedTech halts Varipulse PFA cases due to stroke reports
Johnson & Johnson MedTech has temporarily paused all U.S. external evaluations and cases using its Varipulse pulse field ablation (PFA) system
J&J Stock Falls After Company Pauses Use of Heart Device
Johnson & Johnson shares are down 3% Wednesday on safety concerns that could dim sales prospects for a new heart device, while its rivals gained. J&J said it temporarily paused the use of the heart device,
Varipulse Heart Device Procedures Paused After Safety Events
Just months after FDA approval, Johnson & Johnson paused the rollout of its Varipulse pulsed field ablation (PFA) platform in the U.S. due to safety reasons. In a U.S. external evaluation cohort, four reported neurovascular events occurred among over 130 cases across 14 sites and 40 operators.
J&J pauses Varipulse pulsed field ablation system's US debut following 4 reports of strokes
“On January 5, 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 its notice.
Johnson & Johnson pauses US rollout of Varipulse heart device after stroke reports
Johnson & Johnson said on Wednesday it temporarily paused the rollout of its Varipulse heart device in the United States as the company investigates four reported stroke events.
Johnson & Johnson MedTech pauses Varipulse rollout in US
Despite the pause, the company clarified that the suspension does not impact commercial activity outside the US.
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J&J Halts Varipulse Field Ablation for AFib
The temporary pause follows reports of four cases of neurovascular events in the US external evaluation study.
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J&J Halts Varipulse Pulsed-Field Ablation Cases in the US
The temporary pause will allow the company to investigate four neurovascular events seen in an external validation study.
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J&J pauses Varipulse PFA cases in US
The temporary halt to investigate reported neurovascular events comes two months after Johnson & Johnson won FDA approval for ...
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J&J Falls — While Boston Scientific, Medtronic Pop — After Strokes Sideline A Key Product
Johnson & Johnson stock skidded Wednesday after the company temporarily paused sales of its pulsed field ablation system.
Bronstein, Gewirtz & Grossman, LLC Initiates an Investigation into Allegations Against Johnson & Johnson (JNJ) And Encourages Investors to Reach Out
NEW YORK, NY / ACCESSWIRE / January 10, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf ...
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Johnson & Johnson stock sinks on Varipulse concerns
The report, spearheaded by analyst Larry Biegelsen, pointed to conversations with physicians and industry contacts indicating that Johnson & Johnson has possibly paused Varipulse procedures because of ...