Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated

Intended purpose

The Resolute Onyx Stent System is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of 2.0 mm to 5.0 mm. The Resolute Onyx Stent is indicated for the treatment of the following patient and lesion subsets: • One month of dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients, including patients who are unable to tolerate long term DAPT • Diabetes Mellitus • Multivessel Disease • Acute Coronary Syndrome (ACS) • Acute Myocardial Infarction (AMI) • Unstable Angina (UA) • Bifurcation Lesions • In-Stent Restenosis (ISR) • Chronic Total Occlusions (CTO) • Total Occlusions (TO) • Left Main (LM) • Small Vessel (SV) The Resolute Onyx Stent is intended to improve coronary luminal diameters of either single or multiple vessels as an adjunct to coronary interventions and to reduce restenosis. The stent is intended as a permanently implanted device.

Functional description

The Resolute Onyx Stent is manufactured from a composite material of cobalt alloy and platinum iridium alloy.The delivery system consists of a balloon-expandable intracoronary stent premounted on the Resolute Onyx RX delivery system with a catheter.The Resolute Onyx Stent with the active drug zotarolimus is intended to reduce the incidence of restenosis in coronary interventions.