BioMime™ Branch Sirolimus Eluting Coronary Stent System

Key feature: controlled drug-release system

The stent coating consists of the active substance — sirolimus — and a biocompatible biodegradable copolymer. The polymer matrix acts as a reservoir for controlled drug release: it regulates the delivery of sirolimus into the vascular wall tissue and is intended to inhibit cellular proliferation.

As the polymer performs its function, it gradually degrades, leaving only the metallic stent scaffold in the vessel.

Scaffold and delivery system design

• L605 cobalt-chromium alloy: the stent is made of L605 cobalt-chromium alloy, which combines the flexibility required to navigate anatomically complex lesions with radial support for the arterial wall.
• Fluoroscopic positioning control: platinum-iridium radiopaque markers located at the distal and proximal ends of the balloon help the physician position the system relative to the ostium of the side branch in a bifurcation.
• Rapid exchange catheter: the rapid exchange delivery system facilitates guidewire-based manipulation and may help reduce procedural handling time.
• Optimized shaft transition: the transition between the proximal and distal sections of the delivery system is designed to help protect the stent from displacement and damage while navigating complex anatomical segments.

Drug action and implantation features

• Antiproliferative action of sirolimus: sirolimus is a macrocyclic lactone with antiproliferative properties. Its release is intended to inhibit cellular proliferation and reduce the risk of neointimal hyperplasia and restenosis.
• Size range for bifurcation anatomy: the available ratios of proximal and distal stent diameters allow configuration selection according to the anatomy of the bifurcation lesion.
• Controlled expansion: the semi-compliant polyamide balloon provides gradual and controlled stent expansion during implantation.

Safety and compatibility

• MR Conditional status: the stent scaffold is MR Conditional. MRI may be performed only in accordance with the scanning parameters specified by the manufacturer.
• Sterile single-use system: the device is supplied sterile and non-pyrogenic, sterilized with ethylene oxide (EO), and intended for single use only.
• Hydrophilic catheter coating: the hydrophilic coating on the distal section of the catheter reduces friction during advancement of the system through the vascular lumen.

Indications for use

• Increasing the lumen diameter of coronary artery side branches.
• Treatment of primary bifurcation lesions in native coronary arteries.
• Use in combination with balloon-expandable stents to restore the geometry of the main vessel.

System components

• Balloon-expandable coronary stent made of cobalt-chromium alloy with a specialized design for side branches.
• Biodegradable polymer coating containing sirolimus.
• Rapid exchange balloon catheter delivery system.
• Radiopaque markers for fluoroscopic control.