Cook Medical Files Pre-Market Approval Application for FDA Approval of Zilver(R) PTX(R) Drug-Eluting Stent Platform
6/11/2010 9:36:45 AM
BLOOMINGTON, Ind.--(BUSINESS WIRE)--Cook Medical has submitted its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the company's unique polymer-free Zilver® PTX® Drug-Eluting Peripheral Stent. Intended for use in patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA), Zilver PTX is a self-expanding, highly durable nitinol stent that uses a proprietary, polymer-free technology to deliver a locally therapeutic dose of paclitaxel, an antiproliferative drug, to the target lesion.
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