in heavily calcified lesions or locations subject to external compression.
may occur if used in patients with active inflammation or infections.
The iCARUS clinical trial demonstrated a 96.4% primary patency rate at 9 months, showing the device is highly effective for vascular treatment. g60511.mp4
As of March 2024, Cook Medical entered an exclusive agreement with Getinge to distribute the iCast system in the United States. Safety and Recalls
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 in heavily calcified lesions or locations subject to
Used for treating iliac arterial occlusive disease (narrowed arteries in the groin/leg area).
In March 2023, Getinge received FDA premarket approval for using the device to treat symptomatic iliac arterial occlusive disease. As of March 2024, Cook Medical entered an
The iCast is a balloon-expandable stent system designed to support and hold open structures within the body.