Indications

The pump is indicated for the continuous regional delivery of the following infusates with arterial administration:

• Cerona Therapeutics Floxuridine for Injection, USP
• Heparinized Saline
• Saline
• Bacteriostatic Water
• Glycerin Injection

The approved labeling for Cerona Therapeutics Floxuridine for Injection, USP stipulates the indications, contraindications, and warnings for use of the drug in the pump.

Bacteriostatic water or saline must be used to achieve the desired concentration of the drug. Heparinized saline can be used during an interruption of Hepatic Artery Infusion therapy to maintain catheter patency.

Glycerin infusion is indicated for patients who are receiving continuous Hepatic Arterial Infusion Chemotherapy. Glycerin infusion is employed as a placebo to keep the catheter patent or to extend the refill interval for patients who require therapy interruption or withdrawal.

The Intera 3000 Hepatic Artery Infusion Pump is indicated for use in the adult population only.

Contraindications

The Intera 3000 Hepatic Artery Infusion Pump is contraindicated for use in patients with

• Known or suspected infection, bacteremia, septicemia or peritonitis.
• Known allergic reaction or other signs of intolerance to implanted devices.
• Emotional or psychiatric problems.
• Insufficient body size to accommodate the physical size of the pump.
• Cerona Therapeutics Floxuridine for Injection, USP should be used with added caution in patients with impaired hepatic or renal function.
• Patients with known disease extending beyond an area capable of infusion must be considered for systemic therapy with other chemotherapeutic agents.

Contraindications relating to the specific drug to be used must be observed and followed per the approved drug labeling.

Warnings

The pump must be implanted and refilled only by qualified medical personnel, knowledgeable in the surgical use and servicing of implantable devices and catheters, and trained specifically to implant or refill the pump.

Use of the pump by personnel not properly trained in its implantation and/or servicing may lead to serious consequences involving either under or over-delivery of drug to the patient. In the event of an over-delivery of drug refer to the approved drug labeling for appropriate action.

Adverse Events

Possible adverse events of the pump are those potential risks associated with any implanted drug delivery device and include: catheter thrombosis, bolus path occlusion, vessel thrombosis, pump dislodgement, seroma, or recurrent hematoma, infection, extravasation, catheter shear, dislodgement or leakage, migration, arterial pseudoaneursym, arterial dissection, and extrahepatic perfusion.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.