đź“Š Evidence-Based Reference
Xience Prime and Xience Prime Ll Everolimus Eluting Coronary Stent System Eecss Xience Xpedition Everolimus Eluting
Summary: The Xience Prime is an everolimus-eluting coronary stent system used primarily in percutaneous coronary interventions. Key evidence highlights its role in reducing target lesion revascularization.
FDA Clearance Information
Pathway ?
PMA
Number ?
P110019 ↗
Decision Date ?
October 24, 2014
Product Code ?
NIQ
Device Class ?
Class 3
Evidence ?
0 studies
The Xience Prime was cleared by the FDA via the PMA pathway on October 24, 2014. It is manufactured by Abbott Vascular and classified as a Class 3 device.
What It Is
The Xience Prime is a drug-eluting stent system that releases everolimus to prevent restenosis in coronary arteries. It is intended for use in patients undergoing percutaneous coronary interventions to treat coronary artery disease.
FDA-Cleared Indications
- The FDA record identifies a change to the device's pyrogen testing process under PMA P110019.
- The device is an everolimus-eluting coronary stent system intended for use in coronary artery revascularization during percutaneous coronary intervention, according to the device type and product code.
Clinical Applications
- Treatment of coronary artery stenosis during percutaneous coronary intervention.
- Placement across a narrowed coronary artery segment to restore and maintain blood flow.
- Drug-eluting stent treatment of coronary artery disease when a coronary stent is clinically indicated.
- Revascularization of native coronary artery lesions using catheter-based stent placement.
Reported off-label uses
- Use in coronary artery or graft locations, lesion types, or patient groups outside the specific FDA-approved labeling may occur in clinical practice, but requires individualized physician judgment and is not encouraged solely on the basis of this record.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials and cohort studies, conducted between 2019 and 2023. These studies focus on procedural characteristics and clinical outcomes of the Xience Prime stent.
Reported Outcomes
Published studies report that the Xience Prime stent is associated with reduced rates of target lesion revascularization. The device has shown favorable outcomes in terms of stent expansion and coverage, contributing to its efficacy in coronary interventions.
Safety Profile
Reported complications include acute stent recoil and late stent thrombosis, although these events are relatively rare. The safety profile is generally favorable, with most studies indicating a low incidence of adverse events.
Evidence Limitations
Current evidence lacks comprehensive data on long-term outcomes beyond the initial follow-up period. Further research is needed to establish optimal stent expansion criteria and to evaluate the long-term safety and efficacy of the device.
Practical Considerations
- The stent is delivered through a coronary catheter and expanded with a balloon under fluoroscopic imaging; access is commonly obtained through the radial or femoral artery.
- Available lengths and diameters vary by model, including the standard Xience Prime and the longer Xience Prime LL configuration. The treating cardiologist selects the size based on vessel diameter and lesion length.
- The system must be compatible with the selected guide catheter, guidewire, delivery system, and vascular access equipment. Device preparation and deployment should follow the current manufacturer instructions for use.
- Patients with a coronary stent may need antiplatelet medication after the procedure. Stopping these medications without the treating cardiologist's direction can increase the risk of stent thrombosis.
- MRI eligibility depends on the specific stent configuration and the conditions in the current labeling. The patient's implant documentation and the MRI facility's safety screening should be checked before scanning.
Frequently Asked Questions
What are the clinical indications for Xience Prime?
The Xience Prime is indicated for use in percutaneous coronary interventions to treat coronary artery disease.
What outcomes have been reported in clinical studies?
Clinical studies have reported reduced rates of target lesion revascularization and favorable stent expansion outcomes.
What complications have been reported?
Safety data indicate rare occurrences of acute stent recoil and late stent thrombosis.
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.