FDA Reveals Details on J&J's Varipulse PFA Device Recall

Johnson & Johnson's recent pause in the use of its Varipulse pulsed field ablation (PFA) device has been further elucidated by the Food and Drug Administration (FDA) in a newly published recall notice. The temporary halt, which lasted approximately five weeks, was initiated in January following reports of neurovascular events in patients treated with the device early in its U.S. launch.

Higher-than-Expected Stroke Rates Prompt Investigation

The FDA's recall notice disclosed that four out of 132 patients treated with Varipulse in the first two months of its U.S. launch experienced a form of stroke shortly after surgery. This translates to a rate of stroke and transient ischemic attack (mini stroke) of around 3%, significantly higher than the typically expected rate of 1% or less for this type of procedure.

Biosense Webster, the J&J business responsible for the Varipulse launch, conducted an investigation into these cases. The findings revealed discrepancies between the actual use of the device and the recommendations provided in the instructions for use. These differences, which could explain the elevated risk of stroke or mini stroke, included:

• Treatment of patients with more advanced forms of irregular heart rhythm
• Increased number of energy deliveries to the heart
• Repeated energy deliveries to the same cardiac location
• Energy deliveries to locations not studied in clinical trials

Updated Instructions and Ongoing Monitoring

In response to these findings, J&J has updated the instructions for use for the Varipulse device. The company is now urging healthcare professionals to strictly adhere to the device's use as studied in clinical trials. Additionally, J&J has announced plans for a post-approval study and has emphasized the known and inherent risk of neurovascular events such as stroke during catheter-based ablation procedures.

The FDA's recall notice also detailed J&J's communication to healthcare professionals, which included information about the planned post-approval study and a reminder of the inherent risks associated with catheter-based ablation procedures.

Market Implications and Competitive Landscape

The recent safety concerns surrounding Varipulse could potentially impact its market performance. J.P. Morgan analysts have suggested that these findings might hinder the product's rollout both in the U.S. and globally. This setback comes at a time when competitors such as Boston Scientific's Farapulse and Medtronic's Affera and PulseSelect—rival PFA devices—have launched without reported safety issues.

RBC Capital Markets analysts believe that while J&J can still drive adoption of Varipulse, the company will need to focus on educating healthcare professionals about the proper use of the device. This educational effort will be crucial in rebuilding confidence in the product and ensuring its safe and effective application in clinical practice.