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Cook Medical files for US approval of Zilver PTX

This article was originally published in Clinica

Executive Summary

Cook Medical (Bloomington, Indiana) has submitted a premarket approval (PMA) application to the US FDA for Zilver PTX, its drug-eluting peripheral stent. Intended for use in patients with peripheral arterial disease in the superficial femoral artery, Zilver PTX is a polymer-free Nitinol stent that elutes paclitaxel. The PMA submission includes data from the ongoing Zilver PTX clinical trial, data from which were reported at EuroPCR last month (www.clinica.co.uk, 7 June 2010). PAD is thought to affect eight million people over the age of 40 in the US.

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