BioMime™ Sirolimus-Eluting Coronary Stent System

Key feature: biodegradable polymer coating and thin-profile scaffold

The stent coating contains sirolimus and a biodegradable polymer matrix. After the drug substance is released, the polymer gradually degrades, leaving the metallic stent scaffold in the vessel.

This approach is intended to provide controlled delivery of the antiproliferative drug during the early post-implantation period and reduce the long-term presence of polymer on the stent surface.

Drug action and biomechanics

• Sirolimus: an antiproliferative drug whose release is intended to reduce the risk of neointimal hyperplasia and restenosis.
• Controlled release: drug release is provided by a blend of biodegradable polymers, PLLA and PLGA.
• Biodegradable polymer matrix: the polymer gradually degrades after performing its function as a drug carrier. The degradation profile and release period should be stated in accordance with the manufacturer’s documentation.

Design and adaptability

• Cobalt-chromium scaffold: the scaffold is made of a cobalt-chromium alloy, allowing a thin strut profile to be combined with radial support and radiopacity.
• Hybrid cell design: closed cells at the stent edges support structural fixation, while open cells in the central section help preserve access to side branches.
• Adaptive geometry: the stent design is intended to reduce shortening during deployment and improve scaffold apposition to the vessel wall in anatomically complex segments.

Delivery system and navigation

• Rapid Exchange delivery system: the Rapid Exchange delivery system facilitates guidewire-based handling and enables manipulation by a single operator.
• Hydrophilic shaft coating: the hydrophilic coating reduces friction and facilitates system advancement through tortuous vascular segments.
• Balloon and radiopaque markers: the balloon design and radiopaque markers help position the system and control stent deployment under fluoroscopy.
• Atraumatic distal tip: the tapered distal tip facilitates passage of the system through lesion segments and is intended to reduce the risk of vessel wall trauma.

Indications for use

• Symptomatic coronary artery disease.
• Stenotic coronary artery lesions, including de novo lesions.
• Increasing the coronary artery lumen and restoring coronary blood flow.

Materials used

• Cobalt-chromium alloy: scaffold material with high strength and corrosion resistance.
• Sirolimus: an antiproliferative drug substance used to reduce the risk of neointimal hyperplasia.
• Biodegradable polymer matrix: a drug carrier that gradually degrades after drug release.

Safety and certification

• MR Conditional status: the stent has MR Conditional status, if confirmed by the manufacturer’s documentation. MRI may be performed only in accordance with the specified scanning parameters.
• Size range: available diameter and length options allow stent selection according to vessel diameter, lesion length, and clinical requirements.
• Sterility and single use: the system is supplied sterile, sterilized with ethylene oxide, and intended for single use, if confirmed by the manufacturer’s instructions.
• Quality control: the device should be used in accordance with the manufacturer’s instructions, sterile medical device handling requirements, and applicable safety standards.