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  1. Device Approvals, Denials and Clearances

Zenith Dissection Endovascular System - P180001

Zenith Dissection Endovascular System - P180001

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: Zenith® Dissection Endovascular System
PMA Applicant: William Cook Europe ApS
Address: Sandet 6, DK 4632, Bjaeverskov, Denmark
Approval Date: December 31, 2018
Approval Letter: Approval Order

What is it? The Zenith Dissection Endovascular System is a flexible, metal tube covered with fabric (stent graft) with an optional bare stent (flexible, metal tube that is not covered with fabric) that are supplied on separate long, thin, tube-like devices (delivery catheters). The Zenith Dissection Endovascular System is intended for the treatment of patients who have a tear (dissection) in the inside lining of the large artery in their chest (descending thoracic aorta), which allows blood to flow between the layers of the aortic wall, causing separation of these layers.

How does it work? The delivery catheter containing the stent graft is inserted into a blood vessel (femoral artery) in the groin through a small incision and is carefully guided within this artery to the location in the aorta where the tear begins (entry tear). The stent graft is then released and self-expands to seal off the entry tearand make a new path for the blood to flow. If needed, the bare stent is then inserted and placed below the stent graft in a similar manner to gently reinforce and hold the layers of the aorta together.

When is it used? The Zenith Dissection Endovascular System is used to treat patients who have a tear in their large artery in their chest.

What will it accomplish? The Zenith Dissection Endovascular System may prevent the aorta from bursting or blocking the blood supply to other areas of the body. If blood continues to flow between the layers of the aortic wall or there are blockages to critical blood vessels, there is a chance that additional treatment will be needed to address these problems.

When should it not be used? The Zenith Dissection Endovascular System should not be used in patients with:

  • Known sensitivities or allergies to stainless steel, polyester, polypropylene, nitinol, or gold.
  • Systemic infection that may increase the risk of endovascular graft / stent infection.

Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data (SSED) and labeling are available online.

Other: