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Mamba and Mamba Flex Microcatheters
Summary: The Mamba and Mamba Flex microcatheters are used in interventional cardiology, particularly for chronic total occlusion (CTO) procedures. They are designed for use by cardiologists in catheterization labs.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K190401 ↗
Decision Date ?
March 15, 2019
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Mamba and Mamba Flex microcatheters were cleared through the FDA 510(k) pathway on March 15, 2019. Manufactured by Boston Scientific, these devices are classified as Class 2 under product code DQY.
What It Is
The Mamba and Mamba Flex microcatheters are specialized devices used in percutaneous coronary interventions (PCI) to navigate and support guidewires through complex vascular pathways. They are designed to enhance deliverability and resistance to deformation, making them particularly useful in challenging procedures such as chronic total occlusions.
FDA-Cleared Indications
- Facilitation of guidewire placement in the coronary and peripheral vasculature.
- Facilitation of guidewire exchange in the coronary and peripheral vasculature.
Clinical Applications
- Guidewire placement during percutaneous coronary intervention.
- Guidewire exchange during coronary catheter-based procedures.
- Guidewire placement in peripheral vascular procedures.
- Guidewire exchange in peripheral vascular procedures.
- Support for guidewire navigation in complex vascular anatomy, including chronic total occlusions, when used within the labeled coronary or peripheral vascular indication.
Reported off-label uses
- Use in selected noncoronary endovascular procedures as a support or exchange catheter may occur in clinical practice, but this is outside the device's stated FDA indication and should follow institutional policy and physician judgment.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The devices are available in different configurations and sizes; selection depends on the target vessel, access system, guidewire, and procedural objective.
- They are used through a compatible guide catheter or sheath and with compatible guidewires. The operator should follow the manufacturer's instructions for use regarding wire compatibility and flushing.
- Advance and withdraw the microcatheter under imaging guidance. Avoid excessive force, sharp bends, or resistance, which can damage the catheter or cause deformation.
- The available FDA record and supplied text do not establish that all Mamba or Mamba Flex configurations are MR Safe or MR Conditional. MRI eligibility should be confirmed in the current product labeling before scanning.
- Contraindications, warnings, and limitations vary by configuration and are listed in the manufacturer's current instructions for use. The device is intended for use by trained clinicians in an appropriately equipped catheterization or endovascular laboratory.
Related Literature
The linked study reviews recent advancements in microcatheter technology, focusing on their role in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). It highlights the improved deliverability and resistance to deformation of newer microcatheters, including the Mamba and Mamba Flex. The study suggests that while these devices offer additional options for guidewire support, further clinical experience and comparative studies are needed to fully understand their effectiveness.
Frequently Asked Questions
What is Mamba and Mamba Flex used for?
These microcatheters are used to facilitate guidewire placement and exchange in coronary and peripheral vasculature, particularly in chronic total occlusion procedures.
What specialties typically use this device?
Interventional cardiologists typically use these devices in catheterization labs during percutaneous coronary interventions.
What are the FDA-cleared indications?
The devices are cleared for facilitating guidewire placement and exchange in coronary and peripheral vasculature, especially in chronic total occlusions.
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.