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Johnson & Johnson MedTech has temporarily halted the US rollout of its Varipulse heart device as it investigates four reported stroke events.
The suspension, which began on 5 January, affects the US External Evaluation and all US Varipulse cases.
Johnson & Johnson MedTech emphasised that the health and safety of patients is of utmost importance.
Despite the pause in the US, the company clarified that the suspension does not impact commercial activity or Varipulse cases outside the country due to the US External Evaluation using a distinct platform configuration.
Since the commencement of the External Evaluation cases with Varipulse in the US, more than 130 cases have been completed across 14 sites with 40 operators.
The company noted that the rollout of the platform has been successful across the globe, with over 3,000 commercial cases completed so far.
Johnson & Johnson MedTech is working to complete the investigation swiftly and resume the US External Evaluation. The company anticipates providing more information in the coming days.
Varipulse delivers ablations at precise locations for potentially increasing safety. It received the US Food and Drug Administration (FDA) approval in November 2024, to treat drug-refractory paroxysmal atrial fibrillation (AFib).
The system is designed to deliver treatment using a single device that integrates pulsed field ablation (PFA) therapy with advanced mapping capabilities.
Last month, the FDA granted premarket approval (PMA) to Johnson & Johnson MedTech’s Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps, allowing their usage in paediatric patients with acute decompensated heart failure (ADHF) and cardiogenic shock.
"Johnson & Johnson MedTech pauses Varipulse rollout in US" was originally created and published by Medical Device Network, a GlobalData owned brand.
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