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

Intended purpose

The 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. The Onyx Frontier 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 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)

Functional description

The Onyx Frontier stent is manufactured from cobalt platinum iridium alloy. The delivery system consists of a balloon-expandable intracoronary stent premounted on the delivery system with a catheter; for stent sizes 2.0–4.0mm and 4.5 and 5.0mm, the stent is delivered by the Onyx Frontier and Resolute Onyx rapid exchange (RX) delivery system, respectively. The Onyx Frontier stent with the active drug zotarolimus is intended to reduce the incidence of restenosis in coronary interventions.