Firehawk Liberty Rapamycin Target Eluting Coronary Stent System - Drug-eluting coronary artery stent, biodegradable-polymer-coated

Intended purpose

The Firehawk Liberty™ Rapamycin Target Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 60 mm) with reference vessel diameters of ≥ 2.25 to ≤ 4.0 mm.

Functional description

The product is a device/drug combination product consisting of a) a stent coated with rapamycin in a biodegradable polymer which filled in grooves on the outer surface of stent struts; and b)a rapid exchange (RX) delivery catheter. The stent is left in the vessel to permanently support the vessel. Rapamycin is abluminal on stent struts and is slowly eluted to inhibit proliferation of smooth muscle cells. The coating will degrade and eventually the stent becomes a metal stent.