đź“‹ FDA Reference
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.
FDA-Cleared Indications
- FDA PMA supplement P110013 documented transfer of component-extrusion manufacturing operations from the Santa Rosa facility to the Danvers facility.
- The underlying device is indicated for placement in coronary arteries during percutaneous coronary intervention, according to the approved product labeling.
Clinical Applications
- Catheter-based treatment of a narrowed coronary artery with stent placement.
- Treatment of a coronary artery blockage after balloon angioplasty or another lesion-preparation technique.
- Placement of a drug-eluting stent to support the treated coronary artery and reduce the risk of tissue growth that can cause restenosis.
- Use during hospital-based percutaneous coronary intervention by trained interventional cardiology teams.
Practical Considerations
- The system is available in multiple stent diameters and lengths; the selected size must match the coronary vessel and lesion being treated.
- It is delivered through a coronary angioplasty catheter using fluoroscopic imaging and standard percutaneous coronary intervention equipment.
- Patients require assessment for factors such as inability to receive antiplatelet therapy, active bleeding, severe allergy to device materials or contrast, and unsuitable vessel anatomy.
- MRI conditions, including field strength and waiting requirements, should be confirmed in the current physician labeling before scanning.
- The stent is intended to remain permanently in the coronary artery. Antiplatelet treatment after implantation is prescribed according to the cardiologist's assessment and current guidelines.
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.