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  1. Device Approvals, Denials and Clearances

Resolute Onyx Zotarolimus Eluting Coronary Stent System - P160043/S012

Resolute Onyx Zotarolimus Eluting Coronary Stent System - P160043/S012

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: Resolute Onyx Zotarolimus Eluting Coronary Stent System
PMA Applicant: Medtronic, Inc.
Address: 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: December 14, 2018
Approval Letter: Approval Order

What is it? The Resolute Onyx Zotarolimus Eluting Coronary Stent System is a drug-coated device that contains two components: the stent and the catheter delivery system with a balloon that will inflate to deploy the stent. The stent is placed into a blood vessel (coronary artery) supplying blood to the heart and helps to keep the coronary artery open. The current approval expands the indications for use to include treatment of a blocked coronary artery (chronic total occlusion).

How does it work? The Resolute Onyx Stent delivery catheter is inserted into a blood vessel in the groin or arm then positioned at the blockage of the coronary artery. The balloon on the stent delivery system is inflated, which expands the stent and presses it against the coronary artery wall (a procedure known as balloon angioplasty). The stent remains permanently implanted within the coronary artery to help keep the artery open. The drug, Zotarolimus, is released over time into the artery wall around the stent to help prevent the blood vessel from re-narrowing.

When is it used? The Resolute Onyx Zotarolimus Eluting Coronary Stent System is used in patients who have a narrowing in their coronary arteries caused by coronary artery disease - a condition that occurs when the arteries that supply oxygen-rich blood and nutrients to the heart become narrowed or blocked by a gradual build-up of "plaque." Plaque is made of fatty deposits (cholesterol), white blood cells, calcium and scar tissue that collect over time in the coronary arteries. If these arteries become narrowed or blocked, treatment may be required to improve blood flow and increase the supply of oxygen to the heart.

An artery with heavy amounts of plaque that is completely or near completely blocked for an extended period of time is referred to as a chronic total occlusion. The procedures to treat chronic total occlusions are often more difficult and more invasive for the patient than a typical stent placement procedure.

What will it accomplish? The Resolute Onyx Zotarolimus Eluting Coronary Stent System is intended to remain permanently implanted within the coronary artery to help maintain the improved blood flow.

In a clinical study, 183 patients were treated with the Resolute Integrity Zotarolimus Eluting Coronary Stent (another FDA approved stent very similar to the Resolute Onyx Zotarolimus Eluting Coronary Stent). The study measured outcomes through 12 months after the procedure and demonstrated that the rate of major adverse cardiovascular events (defined as death, myocardial infarction, and need for a repeat procedure at the site of the originally placed stent) was lower than the rate that was observed for other stents used to treat chronic total occlusions.

When should it not be used? The Resolute Onyx Zotarolimus Eluting Coronary Stent System should not be used with

  • Patients with known hypersensitivity or allergies to:
    • aspirin, heparin, bivalirudin, clopidogrel, prasugrel, ticagrelor, ticlopidine, drugs such as zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative,
    • cobalt-based alloy (cobalt, nickel, chromium, and molybdenum) or platinum-iridium alloy, and
    • BioLinx® polymer or its individual components.
  • Patients who cannot receive anti-platelet and/or anticoagulation therapy.
  • Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system.

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