Johnson & Johnson said on Wednesday it has temporarily paused the rollout of its Varipulse heart device in the United States, ...
The temporary pause follows reports of four cases of neurovascular events in the US external evaluation study.
Despite the pause, the company clarified that the suspension does not impact commercial activity outside the US.
Johnson & Johnson pauses U.S. Varipulse cases to investigate neurovascular events. The FDA-approved device integrates PFA ...
The temporary halt to investigate reported neurovascular events comes two months after Johnson & Johnson won FDA approval for ...
Johnson & Johnson said on Wednesday it temporarily paused the rollout of its Varipulse heart device in the United States as ...
In that single-arm study, the rate of primary adverse events within 7 days of ablation was 2.9%, with the most common ...
“On January 5, out of an abundance of caution, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and ...
Johnson & Johnson MedTech has temporarily paused all U.S. external evaluations and cases using its Varipulse pulse field ...
The temporary pause will allow the company to investigate four neurovascular events seen in an external validation study.
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 ...
Johnson & Johnson shares are down 3% Wednesday on safety concerns that could dim sales prospects for a new heart device, ...