According to the official Instructions for Use (IFU) , medical professionals should note:
In March 2023, Getinge received FDA premarket approval for using the device to treat symptomatic iliac arterial occlusive disease. 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 According to the official Instructions for Use (IFU)
The iCast is a balloon-expandable stent system designed to support and hold open structures within the body. g60511.mp4