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U.S. Department of Health and Human Services

Medical Devices

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Prometra® Programmable Infusion Pump System - P080012

Picture of the device.This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Prometra® Programmable Infusion Pump System
PMA Applicant:
Medasys, Inc.
Address:
500 International Drive, Suite 200, Mount Olive, NJ 07828
Approval Date:
February 7, 2012
Approval Letter:
http://www.accessdata.fda.gov/ cdrh_docs/pdf8/p080012a.pdf

What is it? The Prometra Programmable Pump is a battery-operated, implantable, programmable infusion pump that delivers Infumorph® (a preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP) into the fluid around the spinal cord (intrathecal space) through an implanted infusion catheter (a long, thin, flexible tube).

The Prometra Programmable Infusion Pump System consists of the Prometra Programmable Pump, an intrathecal catheter, and a programmer.

How Does it Work? Two of the three components of the system are implanted. The pump is implanted under the skin of the abdomen and the catheter is implanted near the spine (mid to lower back). The programmer is not implanted. The Prometra pump contains a drug reservoir which is a space inside the pump that stores the medicine. After it is programmed, the Prometra pump automatically delivers a controlled amount of Infumorph ® through a filter and then into the catheter which is located in the fluid around the spinal cord. Constant pressure on the reservoir pushes the medicine through the filter and then into the catheter. The flow rate is controlled by electronically-controlled valves. The physician adjusts the drug dosing by using an external, hand-held, battery-operated programmer.

The pump has a central refill port that can be felt under the skin. The physician refills the reservoir generally every 30-90 days by accessing this refill port with a thin needle. The reservoir has a capacity of 20 milliliters (mL).

When is it used? An infusion system is typically used when more traditional therapies are considered ineffective or inappropriate. In the case of chronic pain, an infusion system is used when oral, intravenous, or topical medicines fail to provide effective pain relief or cause uncomfortable side effects.

What will it accomplish? The Prometra Programmable Infusion System is used to deliver Infumorph® into the fluid around the spinal cord, which is a more effective way to deliver the medicine.

A clinical trial demonstrated that the Prometra Pump will deliver the drug within a range of 85% to 115% of the programmed rate.

When should it not be used? Implantation of this device is contraindicated when:

  • The presence of infection is known or suspected.
  • The patient’s body size or anatomy is insufficient to allow for the size of the pump or catheter to be implanted.
  • The pump cannot be implanted 1 inch (2.5 cm) or less from the surface of the skin. Deeper implants could prevent refilling of the drug reservoir or prevent programming of the infusion rate.
  • The patient is known or is suspected to be allergic to materials contained in the catheter: silicone rubber, barium sulfate, tungsten, polyacetal resin, ink, stainless steel, hydroglide hydro gel coating, or plastic needle hubs (polypropylene and acrylic based).
  • The patient is known or is suspected to be allergic to materials contained in the pump: titanium, silicone rubber, polyphenylsulfone, silicone adhesive, polyvinylidene fluoride, MP35N metal (nickel-cobalt-chromium-molybdenum alloy), or stainless steel.
  • The patient has previously experienced adverse reactions to implanted devices.
  • The patient has a spinal column anatomy that would block cerebrospinal fluid flow or would prevent intraspinal drug administration.
  • The patient has emotional, psychiatric or substance abuse problems. The medicines these patients take are not allowed with intrathecal drug infusion.
  • The patient has an occupation where he/she would be exposed to high current industrial equipment, powerful magnets or transmitting towers, such as, electricians, electrical engineers or MRI (Magnetic Resonance Imaging) technicians.
  • Contraindications relating to Infumorph® must be observed and followed according to the approved drug labeling.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.