đź“‹ FDA Reference
Mamba and Mamba Flex Microcatheters
Summary: The Mamba and Mamba Flex microcatheters are used in interventional cardiology for chronic total occlusion procedures. They are designed to improve guidewire support and deliverability.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K171452 ↗
Decision Date ?
August 21, 2017
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Mamba and Mamba Flex microcatheters by Boston Scientific were cleared via the FDA 510(k) pathway on August 21, 2017. They are classified as Class 2 devices under product code DQY.
What It Is
The Mamba and Mamba Flex microcatheters are specialized devices used in percutaneous coronary interventions (PCI), particularly for chronic total occlusions (CTO). These microcatheters facilitate the delivery of guidewires through complex vascular pathways by providing enhanced support and flexibility. They are designed to navigate tortuous anatomy and improve procedural success rates.
FDA-Cleared Indications
- Used in percutaneous coronary interventions to facilitate the placement and exchange of guidewires.
- Used to provide support and access during treatment of coronary artery lesions, including chronic total occlusions.
- Intended for use in the coronary vasculature by trained interventional cardiology professionals.
Clinical Applications
- Guidewire delivery and exchange during coronary angioplasty and stent procedures.
- Crossing or attempting to cross chronic total occlusions in coronary arteries.
- Navigating tortuous or technically difficult coronary anatomy during PCI.
- Providing catheter support when treating complex coronary artery disease.
Reported off-label uses
- Use in selected peripheral vascular interventions to support guidewire manipulation may be reported in clinical practice, but this is outside the device's coronary indication and should not be assumed to be FDA-cleared.
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 available catheter sizes and configurations should be matched to the guidewire, guiding catheter, lesion, and coronary anatomy.
- Operators should follow the current manufacturer's instructions for guidewire compatibility, preparation, advancement, flushing, and removal.
- These are single-use devices intended for temporary use during a procedure; they are not left implanted after PCI.
- MRI safety and conditional-use information should be confirmed in the current labeling. The catheter should not be considered MRI-safe solely because it is a microcatheter.
- Potential complications relate to coronary catheterization and may include vessel injury, dissection, perforation, spasm, thrombosis, embolization, bleeding, infection, arrhythmia, myocardial infarction, or the need for urgent surgery.
Related Literature
The linked study reviewed advancements in microcatheter technology, including the Mamba and Mamba Flex, for chronic total occlusion PCI. It highlighted the improved deliverability and deformation resistance of these devices compared to older models. The study emphasized the need for further clinical experience and comparative studies to fully understand their role in contemporary practice. Limitations include the lack of direct comparative effectiveness data.
Frequently Asked Questions
What is Mamba and Mamba Flex used for?
They are used in interventional cardiology for crossing chronic total occlusions in coronary arteries.
What specialties typically use this device?
Interventional cardiologists in catheterization labs use these devices.
What are the FDA-cleared indications?
They are indicated for use in procedures requiring guidewire support and delivery during chronic total occlusion interventions in coronary arteries.
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.