FDA pre market approval for Stellarex drug-coated balloon (DCB), to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease- Spectranetics Corporation
The Spectranetics Corporation has announced receipt of FDA Pre-Market Approval (PMA) of the Stellarex drug-coated balloon (DCB) designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease
Comment:The Stellarex DCB uses EnduraCoat technology, a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site. Spectranetics launched the device in Europe in January 2015.
EnduraCoat Technology gradually releases paclitaxel, an antiproliferative for the prevention of buildup at the treatment site, while keeping it from shedding from the balloon during delivery of the device. Also it seems to work well while actually releasing a smaller dose of paclitaxel than comparable devices.
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