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As of March 2024, Cook Medical entered an exclusive agreement with Getinge to distribute the iCast system in the United States. Safety and Recalls
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
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 iCARUS clinical trial demonstrated a 96.4% primary patency rate at 9 months, showing the device is highly effective for vascular treatment. As of March 2024, Cook Medical entered an
FDA MedWatch - iCast Covered Stent by Atrium Medical: - GovDelivery
Used for treating iliac arterial occlusive disease (narrowed arteries in the groin/leg area). It features a stainless steel scaffold covered with
In March 2023, Getinge received FDA premarket approval for using the device to treat symptomatic iliac arterial occlusive disease.
