Treatment of chronic and acute arterial lesions in the lower limbs below the knee (BTK), as well as popliteal and infrapopliteal lesions with reference vessel diameters of between ≥2 mm and ≤4.50 mm, with the aim of increasing the internal diameter of an artery and consequently improving blood flow in severe claudication or critical limb ischemia.
Sirolimus-eluting peripheral stent
• Stent material: CoCr L605
• Strut thickness: 75 µm – 85 µm depending on stent diameter. Links 70 µm
• % recoil: < 5%
• % shortening at expansion: < 3%
• Drug: Sirolimus 1.4 µg/mm2
• Polymer: Biostable fluorinated acrylate
• Catheter materials: Nylon / Pebax. No latex components.
• Semi-compliant balloon
• Nominal pressure: 9 – 12 atm
• Rated Burst Pressure (RBP): 16 atm
• Average Burst Pressure (ABP): 22 atm
• 2 Pt/Ir radiopaque markers on the catheter delimiting the stent
• Guiding catheter compatibility: 5F
• Catheter’s working length: 142 cm
• Recommended guidewire: 0.014”
• Entry profile: 0.017”
angiolite BTK sirolimus-eluting peripheral stent 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 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 and glossy finish. The stent design is based on a concatenation of cells in the circumferential direction 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. Before positioning, the balloon is folded and the stent is compressed over it. Radiopaque markers are delimiting the length of the stent and 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.
iVascular´s proprietary nanotechnology that provides a durable biostable coating ensuring a homogenous drug elution in the lesion. It is composed of three layers: Fluoropolymer, fluoropolymer + Sirolimus and lastly, a layer of Acrylate.
angiolite BTK has proven its safety and efficacy in the following clinical trials and registries
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