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U.S. Department of Health and Human Services

Medical Devices

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Zilver® PTX® Drug-Eluting Peripheral Stent - P100022

Image of Zilver® PTX Drug-Eluting Peripheral Stent

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Zilver® PTX Drug-Eluting Peripheral Stent
PMA Applicant: Cook, Inc.
Address: 750 Daniels Way, P.O. Box 489, Bloomington, IN 47402-0489
Approval Date: November 14, 2012
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100022a.pdf

What is it? The Zilver® PTX Drug-Eluting Peripheral Stent (Zilver® PTX Stent) is a self-expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps prevent the artery from narrowing again (restenosis).

How does it work?

  • A small incision is made in the groin to insert the Zilver® PTX Stent.
  • The physician then inserts and guides a catheter to the appropriate location in the artery, and deploys the stent.
  • The Zilver® PTX stent remains in the artery permanently acting as a support (scaffold) to hold the artery open so blood can flow through the artery.

When is it used? The Zilver® PTX stent is used to reopen narrowed or blocked arteries in the above-the-knee femoropopliteal (in the thigh) region caused by peripheral artery disease (PAD). Peripheral artery disease is a common circulatory problem in which narrowed arteries reduce blood flow to limbs, usually in the legs.

What will it accomplish? The Zilver® PTX stent acts as a scaffold to:

  • Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD.
  • Improve blood flow to the extremity.

When should it not be used? The device should not be used in patients:

  • with stenosis that cannot be dilated to permit passage of the catheter or proper placement of the stent
  • who cannot receive recommended drug therapy due to bleeding disorders, and
  • women who are pregnant, breastfeeding, or plan to become pregnant in the next 5 years.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.

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