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 Medical: - GovDelivery
The iCast is a balloon-expandable stent system designed to support and hold open structures within the body. g60511.mp4
The iCARUS clinical trial demonstrated a 96.4% primary patency rate at 9 months, showing the device is highly effective for vascular treatment.
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 It features a stainless steel scaffold covered with
in heavily calcified lesions or locations subject to external compression.
According to the official Instructions for Use (IFU) , medical professionals should note: In 2022, Atrium Medical initiated a for certain
Indicated for maintaining open airways in patients with tracheobronchial strictures caused by malignant neoplasms.