G60511.mp4 < SAFE ✯ >

The iCast is a balloon-expandable stent system designed to support and hold open structures within the body.

may occur if used in patients with active inflammation or infections.

Used for treating iliac arterial occlusive disease (narrowed arteries in the groin/leg area). g60511.mp4

FDA MedWatch - iCast Covered Stent by Atrium Medical: - GovDelivery

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 The iCast is a balloon-expandable stent system designed

In March 2023, Getinge received FDA premarket approval for using the device to treat symptomatic iliac arterial occlusive disease.

the stent beyond recommended diameters, as this can lead to stent fracture. FDA MedWatch - iCast Covered Stent by Atrium

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