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xience prime and xience prime ll everolimus eluting coronary stent system eecss xience xpedition everolimus eluting
Abbott Vascular
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.
Clinical Applications
The device is commonly used in scenarios requiring the revascularization of coronary arteries, particularly in patients with coronary artery disease who are undergoing percutaneous coronary interventions.
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.
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.