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  1. Device Approvals, Denials and Clearances

BioMimics 3D Vascular Stent System - P180003

BioMimics 3D Vascular Stent System - P180003

Image of the device.

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: BioMimics 3D Vascular Stent System
PMA Applicant: Veryan Medical Limited
Address: Block 11, Galway Technology Park, Parkmore, Galway, Ireland, H91 VE0H
Approval Date: 10/04/2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180003B.pdf

What is it? The BioMimics 3D Vascular Stent System has two components; (1) a small, spiral tube (stent) made of a nickel and titanium alloy (nitinol) and (2) an over-the-wire stent delivery system. The BioMimics 3D Vascular Stent System is intended for the treatment of narrowing or reduced blood flow in the femoropopliteal artery.

How does it work? The BioMimics 3D Vascular Stent System is placed into the narrowed section of the leg artery (superficial femoral or proximal popliteal artery) using a balloon catheter. The stent is then released (deployed) and opens automatically over the blockage as it is released from the delivery system. The stent placement increases blood flow to the leg by holding the artery wall open. The stent remains permanently implanted in the leg artery and acts as a support for the newly opened section of the blood vessel.

When is it used? The BioMimics 3D Vascular Stent System is used to reopen narrowed regions of a femoropopliteal artery caused by atherosclerosis. Atheroscleros is the collection of fatty substances such as cholesterol that form "plaque" along the lining of the arteries. This narrowing of the femoropopliteal artery may limit blood flow to the leg and lead to pain when walking.

What will it accomplish? The BioMimics 3D Vascular Stent System acts as a support to hold open the narrowed superficial femoropopliteal artery and improve blood flow to the leg.

When should it not be used? The BioMimics 3D Vascular Stent System should not be used in patients:

  • Who have a lesion that prevents crossing or complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system.
  • Who cannot receive specific blood thinning medications, such as aspirin or coumadin, among others.
  • Who have an aneurysm within the area of the lesion.
  • Who have a known hypersensitivity to nickel, titanium, or tantalum.

Additional information (including warnings, precautions, and adverse events):