FDA MedWatch - iCast Covered Stent by Atrium Medical: - GovDelivery
In 2022, Atrium Medical initiated a for certain units due to concerns regarding the balloon or catheter hub separating during removal. This issue was most frequently observed when the device was used "off-label" for vascular conditions before it received official FDA approval for that specific use. Important Usage Precautions g60511.mp4
It features a stainless steel scaffold covered with a thin layer of ePTFE (polytetrafluoroethylene), allowing it to act as a scaffold while providing a barrier against tissue ingrowth. Key Clinical and Regulatory Milestones FDA MedWatch - iCast Covered Stent by Atrium
According to the official Instructions for Use (IFU) , medical professionals should note: Key Clinical and Regulatory Milestones According to the
In March 2023, Getinge received FDA premarket approval for using the device to treat symptomatic iliac arterial occlusive disease.