Indications: Patients with symptomatic ischemic heart disease due to “de novo” stenotic and re-stenotic lesions located in arteries with diameters from 2 mm to 4.5mm.
Patients with occlusive disease due to acute myocardial infarction located in arteries with diameters from 2mm to 4.5mm.
The sirolimus-eluting coronary stent Angiolite, is made from a cobalt-chromium alloy called L605, coated with a mix of sirolimus and last generation of biostable polymers. The stent is pre-mounted on the delivery system that will allow implantation on the coronary lesion to treat, thanks to the inflation of a balloon at the distal end of the catheter.
The stent is manufactured from a metal tube that is laser cut and subsequently subjected to various treatments that will give the surface a smooth, glossy finish. The stent design is based on a concatenation of cells that are connected axially through links to obtain different 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 rapid exchange balloon catheter also called RX, having a single lumen configuration on the proximal part and a coaxial double lumen configuration on the distal part. The catheter has an inflatable segment (balloon) in its distal end. The balloon is designed to achieve different diameters and lengths, engaging the stent in its different configurations and covering the range of lesions to be treated. 2 radiopaque markers are delimiting the length of the stent to facilitate observation under fluoroscopy. When the balloon reaches the lesion and is inflated, the stent expands against the artery. Subsequently, the balloon is deflated and removed and the stent remains permanently implanted.
The distal part of the catheter is coated with a durable hydrophilic coating to minimize friction and improve its trackability. The inflatable segment is coated with a homogeneous mixture of the drug Sirolimus (Rapamycin) and a biostable fluoro acrylate polymer yielding a drug dose of 1.4 µg/mm2.
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