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  1. Device Approvals, Denials and Clearances

Eluvia Drug-Eluting Vascular Stent System - P180011

Eluvia Drug-Eluting Vascular Stent System - P180011

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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: Eluvia Drug-Eluting Vascular Stent System
PMA Applicant: Boston Scientific Corporation
Address: Three Scimed Place, Maple Grove, Minnesota 55311
Approval Date: September 18, 2018
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf18/P180011A.pdf

What is it? The Eluvia Drug-Eluting Vascular Stent System (Eluvia Stent) is a self-expanding, small metal (nitinol), mesh tube (stent) intended to be implanted in an artery in the thigh (femoropopliteal artery). The Eluvia stent is coated with the drug Paclitaxel,  which help prevent the artery from re-narrowing (restenosis).

How does it work? A small incision is made in the groin to insert the Eluvia Stent System. The physician then inserts and guides the delivery catheter to the appropriate location in the artery and deploys the stent. The Eluvia stent remains in the artery permanently as a support to hold the artery open so blood can flow through the artery.

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

What will it accomplish? The Eluvia Stent acts as a support to hold open a narrowed artery and improve blood flow in the thigh (femoropopliteal artery) caused by PAD.

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

  • With narrowed arteries that cannot be dilated to allow passage of the catheter or proper placement of the stent;
  • Who cannot receive the 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 (including warnings, precautions, and adverse events): The Summary of Safety and Effectiveness Data and labeling are available online.