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),
Varipulse Heart Device Procedures Paused After Safety Events
In that single-arm study, the rate of primary adverse events within 7 days of ablation was 2.9%, with the most common complication being pericardial tamponade (1.1%), and a few cases of stroke (0.7%) and transient ischemic attack (0.4%).
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.
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,
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.
J&J pauses rollout of heart device in the US to investigate stroke risk
(Reuters) -Johnson & Johnson said on Wednesday it has temporarily paused the rollout of its Varipulse heart device in the United States, citing an abundance of caution as the company investigates four reported stroke events.
J&J pauses Varipulse cases on stroke concerns
Johnson & Johnson halted the limited rollout of its Varipulse pulsed field ablation system on Jan. 5 to “investigate the root causes of four reported neurovascular events in the U.S. external evaluation.
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.
TCTMD1d
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.
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 ...
Johnson & Johnson announces pause of all U.S. Varipulse cases
Johnson & Johnson announced that on January 5, “out of an abundance of caution,” Johnson & Johnson MedTech temporarily paused the U.S.
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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.
Investing1d
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 ...