Resolute Onyx Zotarolimus-Eluting Coronary Stent System – P160043/S034
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 Vascular
Address: 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: September 22, 2020
Approval Letter: Approval Order
What is it?
The Resolute Onyx Zotarolimus-Eluting Coronary Stent System is intended to treat a narrowed blood vessel (coronary artery) caused by coronary artery disease. The system consists of a catheter delivery system and a drug eluting stent. The drug eluting stent is manufactured by coating a metallic stent substrate (a cobalt-based alloy shell and a platinum-Iridium alloy core) with the drug matrix consisting of a drug substance (zotarolimus) and a Medtronic’s proprietary BioLinx polymer. The nominal drug content of the stent is 1.6 µg Zotarolimus per mm².
How does it work?
A physician inserts the stent’s delivery balloon catheter into a blood vessel in the patient’s arm or groin. The stent is then positioned at the site of the coronary artery and the balloon is inflated, which expands the stent and presses it against the coronary artery wall. The stent remains permanently implanted within the coronary artery to help keep it open and improve the supply of blood and oxygen to the heart. The drug (zotarolimus) is released over time from the Resolute Onyx Stent surface into the coronary artery wall to help prevent re-narrowing of the coronary artery.
When is it used?
The Resolute Onyx Stent is used in patients who have a narrowing in their coronary arteries and are at high risk for bleeding due to previous conditions such as advanced age, the need for chronic or lifelong blood thinners (anti-coagulants), history of major bleeding, history of stroke, and insufficient kidney function.
This approval expands the indications for use to include patients who have a high risk for bleeding.
What will it accomplish?
In the primary clinical study, 1506 patients at high risk for bleeding and met the one-month clear criteria were treated using the Resolute Onyx stent. Most were able to stop taking one of their two blood thinner medications (antiplatelet therapy) after one month. The results showed that patients with the stent who stopped taking one blood thinner after a month but kept taking their other blood thinning medication were not at increased risk of death or heart attack (myocardial infarction) in the first year. Additionally, these patients had a similar frequency of blood clots forming blockages inside the stent (rate of stent thrombosis) during the first year compared to reports for other drug-eluting stents.
When should it not be used?
The Resolute Onyx Zotarolimus-Eluting Coronary Stent System should not be used in patients with:
- Known hypersensitivity or allergies to aspirin, heparin, bivalirudin, clopidogrel, prasugrel, ticagrelor, ticlopidine, drugs such as zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs, analogues or derivatives
- Known hypersensitivity to specific metals such as the cobalt-based alloy (cobalt, nickel, chromium, and molybdenum) or platinum-iridium alloy
- Known hypersensitivity to the BioLinx polymer or its individual components
- Inability to have anti-platelet and/or anticoagulation therapy
- Inability to have complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery device