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resolute integrity rx zotarolimus-eluting coronary stent system
Medtronic Vascular
Summary: The Resolute Integrity RX is a zotarolimus-eluting coronary stent system used to treat coronary artery disease. It is primarily used by interventional cardiologists in catheterization labs.
FDA Clearance Information
Pathway
PMA
Number
P110013 ↗
Decision Date
November 16, 2021
Product Code
NIQ
Device Class
Class 3
Evidence
0 studies
The Resolute Integrity RX was cleared by the FDA under PMA P110013 on November 16, 2021. Manufactured by Medtronic Vascular, it is a Class 3 device.
What It Is
The Resolute Integrity RX is a drug-eluting stent system designed to open narrowed or blocked coronary arteries. It releases zotarolimus, a drug that helps prevent restenosis by inhibiting cell proliferation. The stent is delivered via a catheter and expands within the artery to maintain blood flow.
Clinical Applications
This stent is commonly used in percutaneous coronary interventions (PCI) to treat patients with coronary artery disease. It is particularly useful in patients with complex lesions or those at high risk of restenosis. Interventional cardiologists deploy this device in hospital catheterization labs during minimally invasive procedures.
Indications for Use
The FDA indications note a manufacturing site change, but clinically, this device is used for patients with coronary artery disease requiring stent placement to restore adequate blood flow and prevent artery re-narrowing.
Practical Considerations
The Resolute Integrity RX is available in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard PCI techniques and equipment, making it versatile for various clinical scenarios.
Frequently Asked Questions
What is the Resolute Integrity RX used for?
It is used to treat coronary artery disease by keeping arteries open and reducing the risk of restenosis.
What specialties typically use this device?
Interventional cardiologists primarily use this device in catheterization labs.
What are the FDA-cleared indications?
The FDA clearance involved a manufacturing site change, but clinically, it is indicated for treating coronary artery disease.
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.