đź“Š Evidence-Based Reference
elunir ridaforolimus eluting coronary stent system
Medinol
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.
Clinical Applications
The EluNIR stent is commonly used in patients undergoing percutaneous coronary intervention, especially those with small vessel coronary artery disease or at high bleeding risk. It is designed to minimize restenosis and improve long-term outcomes.
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.
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.