Dive Brief:
- The Food and Drug Administration shared additional information on the now-resolved pause in the use of Johnson & Johnson’s Varipulse pulsed field ablation (PFA) device.
- J&J paused U.S. Varipulse use in January after seeing neurovascular events early in the launch. The company restarted cases roughly five weeks later after finding the devices work as intended.
- On Friday, the FDA published details of the investigation in a recall notice, explaining that the higher-than-expected rate of stroke or mini stroke could be addressed through patient selection.
Dive Insight:
Four of the 132 patients treated with Varipulse in the first two months of the U.S. launch had a form of stroke shortly after surgery. The rate of stroke and transient ischemic attack, the medical term for a mini stroke, was around 3%. The FDA said a rate of 1% or less is typically expected for this surgery.
Biosense Webster, the J&J business behind the Varipulse launch, investigated the stroke and mini stroke cases. The investigation found differences between how the device was used and the recommendations in the use instructions, the FDA said.
“These differences could explain the higher risk of stroke or mini stroke and include treatment of patients with a more advanced form of irregular heart rhythm, more energy deliveries to the heart, repeated energy deliveries to the same location in the heart and energy deliveries to locations not studied in clinical trials,” the FDA said.
J&J recently updated the instructions for use in light of the findings. The company is asking healthcare professionals to use the device only as it was studied in clinical trials. The FDA shared details of J&J’s letter to healthcare professionals, including notes about a planned post-approval study and the known and inherent risk of neurovascular events such as stroke during catheter-based ablation procedures.
J.P. Morgan analysts last month said J&J’s findings could hinder the product’s rollout in the U.S. and globally. The forecast reflects the availability of Boston Scientific’s Farapulse and Medtronic’s Affera and PulseSelect, rival PFA devices that have launched without safety problems. RBC Capital Markets analysts said J&J can drive adoption but will need to educate healthcare professionals.
