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BioFreedom is a polymer-free and carrier-free drug-coated stent (DCS) developed by Biosensors International for the treatment of coronary artery disease. The device consists of a 316L stainless steel stent platform with a micro-structured abluminal surface that facilitates the controlled release of the active drug, umirolimus (also known as biolimus A9). Umirolimus is a highly lipophilic analog of sirolimus that acts as an mTOR inhibitor, effectively suppressing smooth muscle cell proliferation to prevent restenosis. A key clinical advantage of the BioFreedom stent is its rapid drug transfer to the vessel wall (completed within approximately 28 to 50 hours), which allows for a significantly shortened duration of dual antiplatelet therapy (DAPT)—as little as one month—making it particularly suitable for patients at high bleeding risk (HBR). The stent has received CE Mark approval and has been extensively studied in clinical trials such as LEADERS FREE.
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