The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System), manufactured by BSC, is a device/drug combination product comprised of two regulated components: a device (Coronary Stent System) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).

The SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at high risk for bleeding, with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries >3.50 mm to <5.00 mm in diameter in lesions <28 mm in length.

12-month Target Lesion Failure (TLF) rate, defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.

TLR rate, TLF rate (primary endpoint at 12 months), Target vessel revascularization (TVR) rate, Target vessel failure (TVF) rate, MI (Q-wave and non-Q-wave) rate, Cardiac death rate, Non-cardiac death rate, All death rate, Cardiac death or MI rate, All death or MI rate, All death/MI/TVR rate, Stent thrombosis rates (ARC)