Device Dossier

Ultimaster Nagomi Sirolimus eluting coronary stent system - Drug-eluting coronary artery stent, biodegradable-polymer-coated

Device Dossier for Ultimaster Nagomi Sirolimus eluting coronary stent system - Drug-eluting coronary artery stent, biodegradable-polymer-coated…

Intended purpose

Ultimaster Nagomi Sirolimus eluting coronary stent system is intended to improve myocardial blood flow in patients with stenotic or occlusive lesions in coronary arteries. The stent is indicated (but not limited) to treat patients with chronic coronary syndrome, acute coronary syndrome (STEMI, NSTEMI & unstable angina), diabetes mellitus, multivessel disease, bifurcation lesions, patients older than 65 years, male & female, patients with totally occluded lesions, long lesions, lesions residing in small coronary vessels, restenotic lesions including in-stent restenosis, ostial lesions, lesions in left main coronary artery & arterial or venous bypass graft. Suitable for both femoral & radial approach.

Functional description

chromium alloy (CoCr) stent with abluminal drug eluting coating, that is a blend of Sirolimus and poly (D,L-lactide-co-caprolactone), pre-mounted onto a high pressure, semi-compliant balloon delivery catheter. The catheter has two radiopaque markers, which fluoroscopically mark the ends of the stent to facilitate proper stent placement. A partial hydrophilic polymer coating of the catheter surface generates lubricity when wet.

TGA Public Summary