đź“Š Evidence-Based Reference
Elunir Ridaforolimus Eluting Coronary Stent System
Summary: The EluNIR Ridaforolimus Eluting Coronary Stent System is a drug-eluting stent designed for coronary artery disease. It is primarily used in percutaneous coronary interventions, particularly in patients with small vessel disease. Key evidence highlights its efficacy in reducing restenosis and target lesion failure.
FDA Clearance Information
Pathway ?
PMA
Number ?
P170008 ↗
Decision Date ?
May 21, 2021
Product Code ?
NIQ
Device Class ?
Class 3
Evidence ?
0 studies
The EluNIR stent received FDA clearance via the PMA pathway on May 21, 2021. Manufactured by Medinol, it is classified as a Class III device.
What It Is
The EluNIR Ridaforolimus Eluting Coronary Stent System is a drug-eluting stent that releases ridaforolimus to prevent restenosis. It is used in percutaneous coronary interventions to treat coronary artery disease, particularly in small vessels.
FDA-Cleared Indications
- FDA approval covered extension of the device shelf life from two years to three years.
Clinical Applications
- Use as a coronary drug-eluting stent during percutaneous coronary intervention.
- Treatment of coronary artery lesions requiring stent implantation, according to the device labeling.
- Mechanical support of a treated coronary artery after balloon angioplasty.
- Local delivery of ridaforolimus to help reduce renarrowing within the treated coronary segment.
Evidence Summary
The available literature includes 8 studies, comprising RCTs and prospective analyses, with publication years ranging from 2019 to 2024. These studies evaluate the stent's efficacy and safety in various patient populations.
Reported Outcomes
Published studies report that the EluNIR stent is effective in reducing target lesion failure and restenosis in small vessel coronary artery disease. It has shown superiority over bare-metal stents, particularly in high bleeding risk patients with shortened dual antiplatelet therapy.
Safety Profile
Reported complications include an increased risk of adverse cardiovascular events in small vessel interventions. However, the stent has demonstrated a favorable safety profile compared to first-generation drug-eluting stents.
Evidence Limitations
Current evidence is limited by the lack of long-term follow-up data and the need for more diverse patient populations. Further research is needed to evaluate the stent's performance in different clinical scenarios and its long-term safety.
Practical Considerations
- The available stent diameters, lengths, delivery-system profile and lesion requirements must be confirmed in the current FDA-approved instructions for use.
- The stent is delivered through a coronary catheter and deployed under fluoroscopic angiographic guidance, usually with local anesthesia and procedural sedation as needed.
- Patients generally require antiplatelet therapy after implantation; the treating cardiologist determines the medication and duration based on the clinical situation.
- MRI conditions, including field strength and waiting requirements, must be checked in the current labeling before an MRI examination.
- Contraindications and warnings include allergy or intolerance to device materials or antiplatelet therapy, inability to take recommended antiplatelet medication, and clinical or anatomic factors that make coronary stenting unsuitable.
Frequently Asked Questions
What are the clinical indications for EluNIR stent?
The EluNIR stent is indicated for use in percutaneous coronary interventions, particularly in patients with small vessel coronary artery disease and those at high bleeding risk.
What outcomes have been reported in clinical studies?
Clinical studies have reported reduced target lesion failure and restenosis rates, with improved outcomes in small vessel disease and high bleeding risk patients.
What complications have been reported?
Safety data indicate an increased risk of adverse cardiovascular events in small vessel interventions, though the stent has a favorable safety profile compared to earlier drug-eluting stents.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.