SYNERGY XD MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System - Drug-eluting coronary artery stent, biodegradable-polymer-coated

Intended purpose

The SYNERGY {MEGATRON, XD} Stent System is intended to improve luminal diameter in native coronary arteries with discrete, de novo stenosis in patients with symptomatic ischemic heart disease; including those with acute coronary syndromes (acute myocardial infarction and unstable angina), diabetes mellitus, or renal failure. In addition, the SYNERGY XD Stent System is intended for treatment of patients at high risk of bleeding with as short as one month of dual antiplatelet therapy (DAPT).

Functional description

The SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System is mounted on a balloon expandable delivery catheter, is inserted percutaneously and advanced through the vasculature to the site of the lesion. The balloon is then inflated to expand the stent to the appropriate diameter. Finally, the balloon is deflated and the balloon catheter removed, leaving the stent in position.