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Mynx Vascular Closure Device Product Family
Product: Mynx Control — all models and sizes
Summary: The Mynx Vascular Closure Device is used to seal vascular access sites post-catheterization procedures. It is primarily used by interventional cardiologists and radiologists to achieve hemostasis.
FDA Clearance Information
Pathway ?
PMA
Number ?
P040044 ↗
Decision Date ?
April 30, 2014
Product Code ?
MGB Device, Hemostasis, Vascular
Device Class ?
Class 3
Evidence ?
0 studies
The Mynx Vascular Closure Device, manufactured by Cordis Us, received FDA clearance under PMA P040044 on April 30, 2014. It is a Class 3 medical device.
What It Is
The Mynx Vascular Closure Device is designed to close femoral artery access sites following catheterization procedures. It uses a polyethylene glycol (PEG) sealant that expands upon contact with blood, creating a secure closure. This device helps reduce time to hemostasis and ambulation, improving patient comfort and reducing complications associated with manual compression.
FDA-Cleared Indications
- The FDA-approved indication is reduction of the pouch seal sampling plan.
- The device is intended for use to achieve hemostasis at femoral artery access sites after catheterization procedures, consistent with the authorized labeling.
Clinical Applications
- Closure of femoral artery access sites after diagnostic angiography.
- Closure after percutaneous coronary intervention, including angioplasty and stent placement.
- Closure after other catheter-based procedures performed through a femoral arterial sheath.
- Use in hospital or outpatient catheterization settings when the patient is an appropriate candidate for vascular closure.
Practical Considerations
- The device is intended for femoral arterial access sites and should be used only with the access-site anatomy, sheath size and procedural conditions specified in the current instructions for use.
- Available device sizes correspond to different compatible access-sheath sizes; the correct size must be selected before deployment.
- Deployment requires training in vascular closure-device use and assessment of the puncture site and femoral vascular anatomy.
- Severe peripheral arterial disease, abnormal femoral anatomy, difficult or high arterial puncture, infection at the access site and other conditions may increase risk or make the device unsuitable.
- MRI safety and conditions depend on the current device labeling. The treating team should verify the exact model and consult the latest manufacturer MRI information before an MRI examination.
Frequently Asked Questions
What is Mynx Vascular Closure Device used for?
It is used to seal femoral artery access sites following catheterization procedures to achieve hemostasis.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for reducing the time and complexity of achieving hemostasis at femoral artery access sites post-catheterization.
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.