SLIM Microcatheter
FDA Clearance Information
FDA-Cleared Indications
- Percutaneous catheter access to the neurovasculature for endovascular procedures.
- Use in the delivery or placement of compatible devices, diagnostic agents, or therapeutic materials when specified in the product labeling.
Clinical Applications
- Selective catheterization of intracranial or other neurovascular vessels during endovascular treatment.
- Delivery of compatible embolic materials or therapeutic devices when included in the device's cleared labeling.
- Use with fluoroscopic imaging and compatible guidewires during minimally invasive neurovascular procedures.
Reported off-label uses
- Selective catheterization and embolization in non-neurovascular territories, such as uterine, prostatic, genicular, ovarian, visceral, bronchial, or gastrointestinal arteries, when the catheter's specifications permit.
- Delivery of embolic agents during tumor embolization or vascular malformation treatment outside the cleared neurovascular indication.
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
- Confirm the catheter's labeled inner diameter, outer diameter, usable length, distal-tip configuration, and compatible guidewire before use.
- The catheter is advanced under fluoroscopic imaging through a vascular introducer or guide catheter; careful flushing and air removal are required before use.
- MRI safety depends on the exact device configuration and the manufacturer's current labeling. Do not assume that the catheter is MRI safe or MRI conditional without checking the instructions for use.
- Potential risks include vessel injury, dissection, perforation, vasospasm, thrombosis, infection, bleeding at the access site, and unintended embolization when therapeutic materials are delivered.
- Contraindications and warnings include inability to safely access the target vessel, severe vascular tortuosity or stenosis, incompatibility with the planned guidewire or treatment material, and known sensitivity to relevant contrast or materials.
Procedures that use this device
Frequently Asked Questions
What is the SLIM Microcatheter used for?
It is a small catheter used to selectively access blood vessels during endovascular procedures. The FDA record classifies it as a percutaneous neurovascular catheter; use should follow the current manufacturer labeling.
Is the SLIM Microcatheter MRI safe?
MRI safety depends on the exact model and labeling. Check the current instructions for use or contact the manufacturer before an MRI; do not assume the catheter is MRI safe or MRI conditional.
What sizes does the SLIM Microcatheter come in?
Available diameter, length, tip, and guidewire-compatibility options depend on the specific configuration. Clinicians should confirm the current product catalog and instructions for use before selecting a size.
How long does a microcatheter last?
The SLIM Microcatheter is generally a single-use device, not an implant intended to remain in the body. It is removed at the end of the procedure unless the labeling specifies otherwise.
How much does the SLIM Microcatheter cost?
The price is usually negotiated between the hospital and supplier and is not generally a separate patient charge. A patient's out-of-pocket cost depends on the procedure, insurance coverage, facility fees, and deductible.