FLEXI-PORT Power Injectable Implantable Port
Product: Flexi-Port — all models and sizes · Where to buy
FDA Clearance Information
FDA-Cleared Indications
- Long-term access to the central venous system for administration of medications, fluids, nutrients, blood products, and blood components.
- Repeated venous access for patients who require ongoing intravenous treatment.
- Power injection of contrast media for diagnostic imaging when the port and injection conditions meet the product labeling.
Clinical Applications
- Repeated intravenous chemotherapy or other prescribed drug infusions.
- Administration of intravenous fluids, parenteral nutrition, blood products, or blood components.
- Blood sampling when permitted by the device instructions for use and institutional protocol.
- Power injection of contrast media for CT or other diagnostic imaging when the port is labeled for that use and the specified flow rate and pressure limits are followed.
Reported off-label uses
- Selected long-term intravenous antibiotic treatment when a port is clinically appropriate.
- Long-term administration of outpatient intravenous medications not specifically identified in the device labeling.
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 port is implanted beneath the skin, commonly in the upper chest, with the catheter tip positioned in a large central vein such as the superior vena cava or at the cavoatrial junction.
- Port and catheter dimensions, catheter length, and needle type should be selected for the patient's anatomy and treatment plan. Only non-coring needles designed for implanted ports should be used.
- Power injection is allowed only if the specific port is labeled for power injection and the injector settings, needle type, flow rate, pressure limit, and contrast conditions follow the instructions for use.
- MRI safety depends on the complete implanted system and its labeling. The port should be identified before MRI, and the MRI facility should follow the manufacturer's conditions for scanning.
- Potential contraindications or precautions include infection at the implantation site, bloodstream infection, inadequate venous access, thrombosis, coagulopathy, or inability to safely implant or maintain the device.
Procedures that use this device
Frequently Asked Questions
What is the FLEXI-PORT Power Injectable Implantable Port used for?
It provides repeated access to the central bloodstream for intravenous medications, fluids, nutrition, blood products, blood sampling, and power-injected contrast when allowed by the labeling.
Is the FLEXI-PORT implantable port MRI safe?
MRI conditions depend on the specific port and catheter configuration and the manufacturer's labeling. The implanted device should be identified and its MRI conditions confirmed before scanning.
What sizes are available for the FLEXI-PORT implantable port?
Available port and catheter sizes depend on the manufacturer's product configuration. The treating team selects the appropriate size and catheter length based on the patient's anatomy, access vein, and treatment needs.
How long does an implanted port last?
An implanted port can remain in place for months or years when it functions well and is maintained according to clinical protocol. It may need removal for infection, blockage, malfunction, thrombosis, completion of treatment, or another medical reason.
How much does a FLEXI-PORT implantable port cost?
The total cost varies by hospital, procedure, imaging, anesthesia or sedation, follow-up care, and insurance coverage. Patients should ask the treating facility and insurer for a procedure-specific estimate.