The polymer-free Zilver PTX Drug-Eluting Peripheral Stent has been submitted to the US Food and Drug Administration (FDA) for pre-market approval.
Zilver PTX, developed by Cook Medical, is intended for use in patients with peripheral arterial disease in the superficial femoral artery.
The stent is self-expanding, made of durable nylon and uses a polymer-free technology to deliver a locally therapeutic dose of paclitaxel, an antiproliferative drug, to the target lesion.
The application was submitted to the FDA along with the data from the randomised portion of the largest ongoing Zilver PTX clinical trial, which involves 1,276 patients.
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