iVascular advises that product IFUs should be downloaded, issued and reviewed for operators reference before or during procedures with our devices.
iVascular Architect Coronary Stent is a stent made of a Cobalt Chromium alloy called L605. The stent is supplied pre-mounted on a delivery system for its implantation at the coronary lesion to treat, by means of expansion of the balloon located at the distal end of the catheter.
The stent is manufactured by laser cutting of a metallic tube and then it is submitted to several treatments in order to reach a smooth and glossy surface finish. The stent design is based on circumferential cells linking which are axial interconnected means of connecting links that provide different stent longitudinal configurations. On the other hand, the number of radial cells adjustment allows stent expanding to different diameters. It is based on an open-cell design.
The stent delivery system consists on a rapid-exchange balloon catheter. The catheter comprises an inflatable balloon at the distal part. The balloon has different diameters and lengths to fit with the different stent configurations. When the balloon is inflated, it dilates the stent and deploys it against the artery. Afterwards, the balloon is deflated and removed, and the stent remains permanently implanted.
There are marks on the catheter shaft to help the user to calculate the position of the catheter as it is advanced through the guiding catheter without fluoroscopy, so that, when the last mark disappears, the catheter is already near to the tip of the guiding catheter and about to enter the artery.
The distal part of the catheter is coated with a durable hydrophilic coating that minimizes friction and improves catheter trackability.
The maximum guide wire passage diameter must not exceed 0.36mm = 0.014”. Useful length of the catheter is 142cm, while the total length is 150cm.
See IFUs for further information. Available to download.
The device indication is increasing the internal diameter of an artery with the aim of improving blood flow in the following cases: