FDA Approval: Resolute Onyx & Onyx Frontier

The U.S. FDA approved the Resolute Onyx Zotarolimus-Eluting Coronary Stent System and Onyx Frontier Zotarolimus-Eluting Coronary Stent System developed by Medtronic Vascular for treating coronary artery disease involving bifurcation lesions.

What is it?

The Resolute Onyx and Onyx Frontier systems are specially designed coronary stents used to treat narrowed arteries caused by coronary artery disease.

Each system includes:

• A metal stent made from cobalt alloy
• An inner platinum/iridium core
• A catheter delivery system
• Zotarolimus drug coating with BioLinx polymer technology

How does it work?

A doctor inserts the balloon catheter through a blood vessel in the arm or groin and carefully positions the stent inside the blocked coronary artery.

Once the balloon inflates:

• The stent expands against the artery wall
• The artery opens to improve blood flow
• The stent remains permanently implanted
• Zotarolimus is gradually released to help prevent re-narrowing

When is it used?

These stent systems are used for patients with:

• Non-left main bifurcation lesions
• Coronary artery narrowing involving two intersecting vessels
• Cases where provisional stenting of the main vessel is planned

Clinical Study Results

When should it NOT be used?

The Resolute Onyx and Onyx Frontier systems should not be used in patients with allergies or hypersensitivity to:

• Aspirin or anticoagulant medications
• Zotarolimus, sirolimus, tacrolimus, everolimus, or similar drugs
• Cobalt, nickel, chromium, molybdenum, or platinum-iridium alloys
• BioLinx polymer components

Coronary artery stenting should also not be performed in patients who:

• Cannot receive anti-platelet or anticoagulation therapy
• Have lesions preventing proper balloon inflation or stent placement