De novo stenosis or restenosis of a coronary artery with a diameter of 2-4.5 mm in patients with coronary artery disease.
Occlusion of 2-4.5 mm diameter bypass grafts, including saphenous vein grafts, in patients with coronary artery disease.
Obturation of a coronary artery with a diameter of 2-4.5 mm in patients with developed acute myocardial infarction.
The BTK angiolite sirolimus coated peripheral stent is made of a cobalt-chromium alloy called L605 coated with a blend of sirolimus and latest generation biostable polymers. The stent is pre-positioned in the delivery system to allow the lesion to be implanted for treatment by inflating the balloon at the distal end of the catheter. The stent is made from a metal tube that is laser cut and subsequently subjected to various treatments to give the surface a smooth and glossy finish.
The design of the stent is based on the concatenation of cells in the circumferential direction, which are connected in the axial direction by means of links to obtain various longitudinal configurations. Moreover, the adjustment of the number of cells in the radial direction allows the stent to be expanded to different diameters. The result is an open cell design.
The stent delivery system is a quick-exchange balloon catheter, also called RX, having a single proximal lumen configuration and a coaxial configuration with two distal lumens. The catheter has an inflatable segment (balloon) at the distal end.
The balloon is designed to achieve a variety of diameters and lengths, to grip the stent in its various configurations, and to cover the range of lesions to be treated. Before insertion, the balloon is folded and the stent is squeezed over it.
Radiopaque markers limit the length of the stent and facilitate observation during fluoroscopy. When the balloon reaches the lesion and inflates, the stent expands towards the artery.
The balloon is then deflated and removed, and the stent remains permanently implanted. The distal part of the catheter is covered with a durable hydrophilic coating to minimize friction and improve traceability. The inflatable segment is covered with a homogeneous mixture of sirolimus (rapamycin) and biostable fluoroacrylate polymer, which gives a dose of 1.4 μg / mm2.