Evermine50™ Everolimus-Eluting Coronary Stent System
An everolimus-eluting coronary stent system intended to increase vessel lumen diameter in patients with symptomatic coronary artery disease. Designed for the treatment of both *de novo* and restenotic lesions in native coronary arteries.
Key feature: thin-profile cobalt-chromium scaffold
Evermine50™ is based on a cobalt-chromium scaffold with a thin strut profile. This design is intended to reduce trauma to the vessel wall during implantation and support uniform stent deployment.
The thin strut profile may contribute to a more favorable endothelialization process and reduced local inflammatory response, if supported by the manufacturer’s clinical and preclinical data.
Stent architecture
Evermine50™ combines a hybrid cell design — a combination of open and closed elements. This geometry is intended to balance flexibility, vessel wall support, and structural stability during deployment.
- Variable strut width: supports structural stability during implantation.
- Low recoil: elastic recoil after deployment is reported to be less than 4%.
- Minimal length change: foreshortening / lengthening is reported to be less than 1.0%.
Delivery system for complex anatomy
The delivery system is designed to advance the stent through tortuous coronary segments and lesions with complex morphology. The design is intended to support push force transmission, kink resistance, and controlled system advancement.
- Reinforced hypotube: helps maintain steerability and control during system advancement.
- Extended distal tip: facilitates entry into the lesion segment and passage through complex areas.
- Reduced tracking force: lower tracking force may facilitate navigation through anatomically complex coronary segments.
- Platinum-iridium radiopaque markers: help visualize the system and control stent positioning under fluoroscopy.
Clinical data and drug coating
Evermine50™ clinical data include safety and efficacy outcomes during follow-up, including in patients with concomitant risk factors. Specific values should be stated only with reference to the study, number of patients, follow-up period, and assessment criteria.
- Stent thrombosis: the 0.0% ST rate may be stated only with reference to the specific study and follow-up period.
- MACE: the 0.8% MACE rate also requires indication of the source, study design, and patient population.
The stent drug coating contains everolimus and a biocompatible biodegradable copolymer.
- Everolimus: an antiproliferative drug substance whose release is intended to reduce the risk of neointimal hyperplasia and restenosis.
- Biodegradable copolymer: the polymer matrix serves as a drug carrier and provides controlled drug release.
- Polymer degradation: after release of the drug substance, the polymer gradually degrades. The degradation period and release profile should be stated in accordance with the manufacturer’s documentation.
Indications and areas of use
- Symptomatic coronary artery disease.
- Primary coronary artery lesions, including de novo lesions.
- Restenosis in previously implanted stents, if specified in the manufacturer’s instructions.
- Use in patients indicated for percutaneous transluminal coronary angioplasty, in accordance with the official indications.
Materials used
- L605 cobalt-chromium alloy: scaffold material that combines a thin strut profile with radial support.
- Platinum and iridium: used in radiopaque markers for visualization under fluoroscopy.
- Biodegradable lactide- and glycolide-based polymer: drug-coating matrix that provides everolimus release.
System components
- Balloon-expandable coronary stent with a drug coating.
- Rapid Exchange balloon catheter delivery system.
- Protective packaging, including a circular tray and Tyvek pouch, if included in the manufacturer’s configuration.
Certification and safety
- The device has CE marking, if confirmed by current manufacturer documentation.
- The system is sterilized with ethylene oxide (ETO) and supplied non-pyrogenic, if stated in the manufacturer’s instructions.
- The device is intended for single use.
- MR Conditional status: MRI may be performed only in accordance with the scanning parameters specified by the manufacturer. Conditions for 1.5 T and 3.0 T scanners should be stated according to the IFU.
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