VariFuse Adjustable Infusion Catheter
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FDA Clearance Information
FDA-Cleared Indications
- The catheter is indicated for the controlled infusion of thrombolytic agents into peripheral and pulmonary blood vessels.
- It is intended for use in the treatment of thromboembolic disease when thrombolytic therapy is appropriate.
- The device is intended for use by physicians trained in endovascular procedures.
Clinical Applications
- Catheter-directed infusion of thrombolytic medication for selected deep vein thrombosis.
- Infusion-based treatment of selected pulmonary embolism.
- Delivery of thrombolytic medication during endovascular treatment of peripheral venous or arterial thromboembolic disease.
- Use with imaging guidance in a hospital or procedure-room setting.
Practical Considerations
- Use only with the compatible guidewire, infusion system, thrombolytic medication and accessories specified in the current instructions for use.
- The available catheter lengths, diameters and adjustable infusion-segment dimensions should be confirmed before the procedure; sizing depends on the target vessel and clot distribution.
- The catheter is manipulated under fluoroscopic or other appropriate imaging guidance, and correct positioning should be confirmed before medication infusion.
- MRI safety and conditional-use information should be checked in the current FDA-cleared labeling. Do not assume the catheter is safe in the MRI environment.
- Contraindications and precautions include conditions in which thrombolytic therapy or vascular catheterization is inappropriate, such as active bleeding, certain recent surgeries or hemorrhagic stroke; patient selection follows the thrombolytic drug labeling and device instructions.
Procedures that use this device
Frequently Asked Questions
What is the VariFuse Adjustable Infusion Catheter used for?
It is used to infuse thrombolytic medication into blood vessels during catheter-based treatment of thromboembolic disease, including selected deep vein thrombosis and pulmonary embolism cases.
Is the VariFuse Adjustable Infusion Catheter MRI safe?
MRI safety depends on the exact device configuration and the current instructions for use. Confirm the device's MR status before scanning and do not assume it is safe without labeling verification.
What sizes does the VariFuse catheter come in?
Size options include different catheter diameters, lengths and adjustable infusion-segment dimensions. The treating physician selects the configuration based on the target vessel, clot location and required treatment length.
How long does the VariFuse catheter stay in place?
The duration depends on the treatment plan, thrombolytic medication and clot response. It may be used for a procedure lasting hours and is removed when infusion and follow-up imaging are complete.
How much does the VariFuse Adjustable Infusion Catheter cost?
The price varies by hospital, contract, catheter configuration and overall procedure costs. Patients should ask their hospital and insurer about device coverage, thrombolysis charges and facility fees.