the stent beyond recommended diameters, as this can lead to stent fracture.
The iCast is a balloon-expandable stent system designed to support and hold open structures within the body. g60511.mp4
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 the stent beyond recommended diameters, as this can
FDA MedWatch - iCast Covered Stent by Atrium Medical: - GovDelivery This issue was most frequently observed when the
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
in heavily calcified lesions or locations subject to external compression.
In March 2023, Getinge received FDA premarket approval for using the device to treat symptomatic iliac arterial occlusive disease.