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MDK-1901 is a sirolimus-eluting balloon (SEB) developed by MedAlliance (now a Cordis company) for the treatment of peripheral arterial disease (PAD), specifically targeting stenosis in the superficial femoral artery (SFA) and popliteal artery. The device employs a unique Cellular MicroReservoirs (CMR) technology, which consists of thousands of micro-sized particles made of a biodegradable polymer (poly-L-lactic acid) encapsulated with sirolimus. These microreservoirs are applied to the balloon surface and transferred to the vessel wall during inflation, where they provide a controlled and sustained release of the drug for over 90 days. This approach aims to maintain vessel patency by inhibiting the mTOR pathway, which suppresses the inflammatory and proliferative responses that lead to restenosis, while avoiding the long-term complications associated with permanent metallic stents.
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