G60511.mp4 File

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 iCARUS clinical trial demonstrated a 96.4% primary patency rate at 9 months, showing the device is highly effective for vascular treatment.

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

Indicated for maintaining open airways in patients with tracheobronchial strictures caused by malignant neoplasms. In 2022, Atrium Medical initiated a for certain

According to the official Instructions for Use (IFU) , medical professionals should note:

Used for treating iliac arterial occlusive disease (narrowed arteries in the groin/leg area). FDA MedWatch - iCast Covered Stent by Atrium

in heavily calcified lesions or locations subject to external compression.