đź“Š Evidence-Based Reference
Xience V Everolimus Eluting Coronary Stent System Xience Nano Everolimus Eluting Coronary Stent System
Summary: The Xience V Everolimus Eluting Coronary Stent System by Abbott Vascular is used in percutaneous coronary interventions. It is FDA PMA cleared with evidence supporting its efficacy and safety in treating coronary artery disease.
FDA Clearance Information
Pathway ?
PMA
Number ?
P070015 ↗
Decision Date ?
April 16, 2018
Product Code ?
NIQ
Device Class ?
Class 3
Evidence ?
0 studies
The Xience V Everolimus Eluting Coronary Stent System was cleared by the FDA via the PMA pathway on April 16, 2018. It is manufactured by Abbott Vascular and classified as a Class 3 medical device.
What It Is
The Xience V Everolimus Eluting Coronary Stent System is a drug-eluting stent designed to release everolimus, an immunosuppressant drug, to prevent restenosis in coronary arteries. It is intended for use in patients undergoing percutaneous coronary interventions.
FDA-Cleared Indications
- Addition of an alternate contract laboratory for raw-material lot-release tests.
Clinical Applications
- No new patient-facing clinical use is established by the FDA indication text provided for this 2018 PMA record.
- The underlying Xience coronary stent system is used during percutaneous coronary intervention to help treat obstructive coronary artery disease when its applicable FDA-approved labeling criteria are met.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials and meta-analyses, conducted between 2012 and 2018. These studies evaluate the efficacy and safety of the Xience V stent compared to other drug-eluting stents.
Reported Outcomes
Published studies report that the Xience V stent demonstrates favorable clinical outcomes, including low rates of restenosis and stent thrombosis. The stent has shown superiority over paclitaxel-eluting stents in terms of long-term efficacy in coronary artery disease.
Safety Profile
Reported complications include low incidences of stent thrombosis and restenosis. The safety profile of the Xience V stent is supported by multiple randomized controlled trials, indicating a low risk of adverse events.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials specifically addressing very long lesions. Further research is needed to explore long-term outcomes in diverse patient populations.
Practical Considerations
- The record includes both the Xience V and Xience Nano systems; available stent diameters, lengths, delivery-system specifications, and lesion-size limits depend on the specific model and current labeling.
- Placement is performed through catheter access, commonly from the radial or femoral artery, under fluoroscopic imaging by an interventional cardiologist.
- The stent releases everolimus to reduce neointimal growth and restenosis, but patients generally need antiplatelet medication after implantation as directed by their cardiologist.
- MRI eligibility depends on the exact stent model, implanted configuration, field strength, and conditions in the manufacturer’s current MRI labeling. The implant card and device-specific instructions should be reviewed before MRI.
- Potential limitations and risks include coronary artery perforation or dissection, thrombosis, restenosis, bleeding, contrast reaction, kidney injury, and the need for repeat intervention. Contraindications and warnings are device- and patient-specific.
Frequently Asked Questions
What are the clinical indications for Xience V stent?
The Xience V stent is indicated for use in patients with coronary artery disease requiring percutaneous coronary intervention.
What outcomes have been reported in clinical studies?
Studies report low rates of restenosis and stent thrombosis, with favorable long-term outcomes compared to paclitaxel-eluting stents.
What complications have been reported?
Safety data indicate low incidences of stent thrombosis and restenosis, with a favorable safety profile in clinical trials.
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.