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G60511.mp4 -

in heavily calcified lesions or locations subject to external compression.

the stent beyond recommended diameters, as this can lead to stent fracture.

may occur if used in patients with active inflammation or infections. g60511.mp4

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

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

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

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 In March 2023, Getinge received FDA premarket approval

Indicated for maintaining open airways in patients with tracheobronchial strictures caused by malignant neoplasms.