Safety Information For Patients

Intera 3000 Hepatic Artery Infusion Pump

Important: Information on this site is not meant as medical advice and should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

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.

"Doctors told me that my life was likely measured in weeks, not months. Four years later I have resumed my normal activities and spend time playing with my granddaughters and working on my golf swing."

Read the full story ›

Individual results may vary. Talk to your physician about the risks and benefits of HAI therapy and to find out if the Intera 3000 HAI Pump is right for you.
Rick B.
Rick B.

"While an implanted pump is a commitment, I was willing to make it after reading the clinical papers on the benefits the pump can provide."

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Individual results may vary. Talk to your physician about the risks and benefits of HAI therapy and to find out if the Intera 3000 HAI Pump is right for you.
Don S.
Don S.

"When your doctors tell you that you only have a 2% chance of long-term survival, you can’t think about the 98%; you have to focus on how you make that 2% your reality."

Read the full story ›

Individual results may vary. Talk to your physician about the risks and benefits of HAI therapy and to find out if the Intera 3000 HAI Pump is right for you.
Josh G.
Josh G.

"Patients should be the CEO of their treatment. Getting a pump is a powerful treatment that I would choose again if I had to do it all over."

Read the full story ›

Individual results may vary. Talk to your physician about the risks and benefits of HAI therapy and to find out if the Intera 3000 HAI Pump is right for you.
Marsha S.
Marsha S.

"All I wanted was to be a new mom, raise my child, and be with my baby. Stage 4 cancer was not anything I expected at that point in life."

Read the full story ›

Individual results may vary. Talk to your physician about the risks and benefits of HAI therapy and to find out if the Intera 3000 HAI Pump is right for you.
Stacy O.
Stacy O.