Indications, Safety, and Warnings


Indications

The Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length ≤35 mm in native coronary arteries with reference vessel diameters of 2.25 mm to 5.0 mm.

Contraindications

The Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System is contraindicated for use in:

Coronary artery stenting is contraindicated for use in:

Warnings

Precautions

The safety and effectiveness of the Resolute Onyx™ stent have not yet been established in the following patient populations:

The safety and effectiveness of the Resolute Onyx™ stent have not been established in the cerebral, carotid, or peripheral vasculature.

Potential Adverse Events

Other risks associated with using this device are those associated with percutaneous coronary diagnostic (including angiography and IVUS) and treatment procedures. These risks (in alphabetical order) may include but are not limited to:

Adverse Events Related to Zotarolimus

Patients' exposure to zotarolimus is directly related to the total amount of stent length implanted. The actual side effects/complications that may be associated with the use of zotarolimus are not fully known. The adverse events that have been associated with the intravenous injection of zotarolimus in humans include but are not limited to:

Please reference appropriate product Instructions for Use for more information regarding indications, warnings, precautions, and potential adverse events.

CAUTION : Federal (USA) law restricts this device to sale by or on the order of a physician.

1 The 4.5-mm and 5.0-mm diameter stents are not offered on the Over-the-Wire (OTW) delivery system.