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FDA MedWatch - iCast Covered Stent by Atrium Medical: - GovDelivery
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. FDA MedWatch - iCast Covered Stent by Atrium
Indicated for maintaining open airways in patients with tracheobronchial strictures caused by malignant neoplasms. It features a stainless steel scaffold covered with
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 stent beyond recommended diameters, as this can lead to stent fracture.
As of March 2024, Cook Medical entered an exclusive agreement with Getinge to distribute the iCast system in the United States. Safety and Recalls