USA—Johnson & Johnson MedTech has temporarily halted the rollout of its Varipulse heart device in the United States to investigate reports of four stroke incidents.
This suspension, which began on January 5, affects all ongoing US external evaluation cases and new uses of Varipulse within the country.
In their statement, the company reassured the public that patient safety remains its top priority.
However, it clarified that the pause is limited to the United States and does not impact commercial activities or Varipulse procedures in other countries.
The US External Evaluation utilizes a unique platform configuration, which differs from the systems used globally.
Since the start of the US External Evaluation, more than 130 cases have been conducted across 14 sites by 40 operators.
Globally, the rollout of Varipulse has been more extensive, with over 3,000 commercial cases successfully completed.
Despite the temporary setback in the US, Johnson & Johnson MedTech highlighted the system’s worldwide success, underscoring its commitment to advancing heart health.
Varipulse, which received FDA approval in November 2024, is designed to treat drug-resistant paroxysmal atrial fibrillation (AFib).
The device delivers precise ablations and integrates pulsed field ablation (PFA) therapy with advanced mapping capabilities.
This combination aims to enhance both treatment accuracy and patient safety.
The company is working diligently to complete its investigation into the reported stroke events and aims to resume the US External Evaluation as soon as possible.
More updates are expected in the coming days.
Meanwhile, Johnson & Johnson MedTech has continued to expand its cardiac device offerings.
In December 2024, the FDA granted premarket approval (PMA) for its Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps.
These devices are now approved for use in pediatric patients with acute decompensated heart failure (ADHF) and cardiogenic shock, marking a significant milestone in pediatric cardiac care.
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