BioMime Aura™ Sirolimus-Eluting Coronary Stent System

Key feature: Morphology Mediated Expansion™ technology

The architecture of the BioMime Aura stent is designed with consideration for the natural morphology and geometry of the vessel. The hybrid cell design — closed cells at the edges and open cells in the central section — is intended to improve scaffold apposition to the arterial wall while preserving access to side branches.

Combined with an ultra-thin strut profile, this design provides system flexibility while maintaining radial vessel support.

Design and biomechanics

The stent design is intended to achieve acute lumen gain and reduce procedural risks during implantation.

• Minimal shortening and recoil: low shortening and elastic recoil help support accurate stent positioning and preservation of the intended diameter after deployment.
• Hybrid cell design: the combination of open and closed cells provides arterial wall support along the treated segment and helps preserve access to side branches.
• Radiopaque markers: platinum-iridium markers improve visualization of the system during fluoroscopic positioning control.

Delivery system and handling

The delivery system is designed to advance the stent through tortuous vascular segments and lesions with complex morphology.

• Navigation through the vasculature: the hydrophilic coating of the distal shaft reduces friction and facilitates system advancement.
• Reinforced hypotube: the hypotube with a tapered transition supports push force transmission from the proximal section to the distal section and helps maintain control of the system.
• Atraumatic distal tip: the extended distal tip and smooth balloon transitions are intended to reduce the risk of vessel wall trauma.
• Inner lumen stability: the use of reinforced materials helps maintain the system lumen during high-pressure stent deployment.

Clinical data and safety

The clinical safety and efficacy of BioMime Aura were evaluated within the meriT program, which included clinical studies and real-world registries with follow-up observation.

• Non-inferiority data: in randomized studies, the system was evaluated for non-inferiority compared with reference stent systems.
• Cardiac events: clinical data report a low rate of MACE — major adverse cardiac events — and repeat revascularization of the target lesion.
• Stent thrombosis and cardiac mortality: data on stent thrombosis and cardiac deaths should be stated only with reference to a specific study, follow-up period, and patient population.

Materials used

The system components are selected with regard to biocompatibility, deliverability, and controlled drug release.

• L605 cobalt-chromium alloy: the scaffold material enables the use of thin struts while maintaining radial support and radiopacity.
• PLLA + PLGA biodegradable polymer: the polymer matrix serves as a drug carrier and gradually degrades after performing its function.
• Sirolimus: an antiproliferative drug whose release is intended to reduce the risk of neointimal hyperplasia and restenosis.

Benefits for the clinic and physician

• System deliverability helps manage lesions with complex morphology.
• The size range allows stent configuration to be selected according to the diameter and length of the treated segment.
• The system design is intended to improve the predictability of stent positioning and deployment.

Certification and standards

The system complies with applicable safety and quality requirements for medical devices. CE marking, sterility status, and conditions of use should be stated in accordance with the manufacturer’s documentation.

The device is supplied sterile and intended for single use, if confirmed by the manufacturer’s instructions.