CrossFAST Integrated Microcatheter Advanced Delivery System
FDA Clearance Information
FDA-Cleared Indications
- For percutaneous introduction into blood vessels for the delivery of diagnostic or therapeutic agents and materials, consistent with the labeling for this catheter category.
- Use is limited to trained clinicians and the specific device instructions for use, including stated vessel size, access route, and compatibility requirements.
Clinical Applications
- Selective or superselective catheterization of blood vessels during image-guided endovascular procedures.
- Delivery of embolic materials to selected arteries when used according to the device labeling and the embolic agent's instructions.
- Delivery of therapeutic agents or other approved materials during vascular interventions.
- Catheter-based vascular procedures performed by interventional radiology, neurointerventional, vascular, or other appropriately trained specialists.
Practical Considerations
- The available catheter sizes, working length, distal configuration, and compatible guidewire or delivery materials should be confirmed in the current instructions for use.
- The system is intended for use through a compatible vascular access sheath or guide catheter under fluoroscopic or other appropriate imaging guidance.
- Potential contraindications and warnings include inability to safely access the target vessel, severe vessel spasm or tortuosity, thrombosis, dissection, perforation, infection, contrast allergy, and bleeding risk.
- MRI safety depends on the exact device configuration and labeling. Do not assume the system is MR Safe or MR Conditional without checking the current manufacturer instructions.
- Risks are related to both catheterization and the material or treatment delivered, including bleeding, hematoma, embolization to an unintended vessel, ischemia, infection, vessel injury, and contrast-related complications.
Procedures that use this device
Frequently Asked Questions
What is the CrossFAST Integrated Microcatheter Advanced Delivery System used for?
It is a percutaneous microcatheter system used to selectively access blood vessels and deliver diagnostic or therapeutic materials during image-guided vascular procedures. The exact permitted use depends on the current FDA clearance and manufacturer instructions for use.
What sizes does the CrossFAST microcatheter come in?
Available catheter diameters, lengths, distal tips, and compatibility specifications should be confirmed in the current Vantis Vascular product documentation. These details may vary by model and configuration.
Is the CrossFAST catheter MRI safe?
MRI safety cannot be determined from the device name alone. Check the current instructions for use and device labeling for the specific model before an MRI examination.
How long does the CrossFAST catheter last?
The system is generally a single-use device and is not intended for long-term implantation. Its duration in the body depends on the procedure and it is normally removed after the intervention.
How much does the CrossFAST Integrated Microcatheter cost?
The purchase price is not usually publicly listed and varies by hospital, distributor, contract, and configuration. Patient charges depend on the complete procedure, facility, physician, insurance coverage, and any deductible or coinsurance.