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Sirogen (VTI-201) is a sirolimus-eluting collagen implant developed by Vascular Therapies, Inc. to address arteriovenous fistula (AVF) maturation failure in patients with end-stage renal disease. The product is a drug-device combination consisting of a biodegradable collagen matrix impregnated with sirolimus, which is surgically placed around the outside of the vein and artery at the site of the fistula anastomosis. Sirolimus, a potent mTOR inhibitor, is released locally over several weeks to suppress the proliferation and migration of vascular smooth muscle cells, thereby inhibiting neointimal hyperplasia—the primary biological cause of AVF stenosis and failure. By promoting successful vascular remodeling and maturation, Sirogen aims to increase the likelihood of creating a functional hemodialysis access, particularly in elderly patients (aged 65 and older) who typically experience higher rates of AVF failure.
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