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Cardioform Septal Occluder Wins FDA Approval for PFO Closure

— Decision comes nearly a year after positive REDUCE trial

by Nicole Lou, Staff Writer, ľֱ

MedpageToday

The FDA cleared an expanded indication for Cardioform Septal Occluder that now puts the device on the market for patent foramen ovale (PFO) closure to reduce risk of recurrent ischemic stroke, device manufacturer Gore .

While the device had been approved only for the closure of atrial septal defects, the expanded indication rested on data from the REDUCE trial. That 664-person, open-label trial showed a drop in stroke risk when patients with a prior cryptogenic stroke underwent PFO closure with the Helex Septal Occluder or Cardioform Septal Occluder in lieu of medical therapy alone.

In 2016, another device, the Amplatzer PFO Occluder, was approved by the FDA on the basis of safety and a reduction in PFO-related second strokes despite a lack of alleviation in overall stroke risk.

  • author['full_name']

    Nicole Lou is a reporter for ľֱ, where she covers cardiology news and other developments in medicine.