setting a new standard in precision dosing

The Prometra Drug Delivery system brings new levels of accuracy and precision to drug delivery to help treat pain and spasticity.

Accurate & precise

Prometra features our unique Precision Dosing System (PDS) that’s designed to accurately and reliably deliver medicine while minimizing the effect of reservoir volume or environmental factors including temperature and pressure.

The PDS provides multiple benefits for physicians and patients, including:

  • Micro-dosing capabilities
  • A 10+ year battery life
  • Potential for fewer pump replacement procedures

In addition, the programmable infusion system also includes several components that guard against common complications, including:

  • Tissue ingrowth
  • Suture complications
  • Weakened connection
  • Possible issues with refills.

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Prometra Drug Delivery System vs typical pain medications

Typical Pain medications

Often, treatment for chronic pain management includes medication that is taken by mouth. This method of treatment can help some patients manage their chronic pain, but also has several disadvantages:

  • Oral medications take some time to work after they are taken, as they have to travel through the bloodstream before affecting the nerves, brain, and other parts of the body to relieve pain.
  • Oral medications may have several side effects, including drowsiness, confusion, nausea, constipation, and respiratory depression.
  • Oral medications must be remembered and taken by the patient at scheduled times
  • Over time, the body can become accustomed to its dosage, requiring higher doses to manage pain.

Prometra Drug Delivery System

The Flowonix Prometra delivery system is implanted under the skin of the abdomen and connected to a narrow catheter that leads to a targeted area within your spinal cord. The device is filled with a prescribed amount of specialized pain medication. The system is then programmed by your physician to deliver a specific amount of medication at set times. There are several advantages to this targeted therapy over oral pain medication:

  • Medication is delivered to the fluid of the spinal cord, reducing the time between taking oral medication and waiting for it to take effect
  • Medication is automatically delivered, so the patient does not have to remember to take their medication
  • Many patients experience improvement in their everyday activities
  • Many patients find that they are able to reduce or eliminate their oral pain medications

The Prometra drug delivery system has helped many patients have more active lifestyles. If you suffer from a chronic pain condition, use our physician locator to find a provider who performs the implantable drug delivery procedure or talk to your pain doctor about Prometra at your next appointment.

Advantages of Prometra

Chronic pain affects millions of Americans and many have tried several treatments without adequate pain relief. Chronic pain can affect every moment of the day, and unrelenting pain can make it impossible to enjoy simple things like taking a walk, visiting with friends, or even a good night’s sleep. Chronic pain conditions affect patients physically, mentally, and emotionally, and for many, conventional treatments may not be enough. Or, conventional treatments are accompanied by side effects, dosing problems, and other issues that may affect quality of life.

Are there risks?

The Prometra® drug delivery system is surgically implanted under the skin, and all surgery carries some risk. Additionally, there is a risk of infection and spinal fluid leakage.

Once the device is implanted, there is a risk of complications with the device which may require removal of the device. Drug overdose or underdose may occur from device complications, and may have serious or life-threatening effects.

Possible complications may also include movement of the device within the body or wearing through the skin. Parts of the implantable pump system, including the catheter or pump could leak, tear, kink, or become disconnected. It is also possible that the pump may fail to function because of a battery problem or a component failure. In some cases, inflammatory masses have been seen at the tip of the catheter, which may lead to complications including paralysis.

Speak to your doctor regarding possible risks with the Prometra drug delivery system.

Brief Statement for US Health Care Providers
PL-19589-03
Issue date: March 2022
IMPORTANT SAFETY INFORMATION FOR PROMETRA DRUG DELIVERY SYSTEMS – BRIEF STATEMENT

Product technical manuals and the appropriate drug labeling must be reviewed prior to use for detailed disclosure. Clinicians implanting, programming, accessing, or maintaining implanted programmable pumps must comply with the instructions for use.

Indications: The Prometra® Programmable Infusion Pump System is indicated for intrathecal infusion of drug therapy, including: Infumorph® (preservative free morphine sulfate sterile solution), preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP), and baclofen (baclofen injection, intrathecal, 500-2000 mcg/mL). For Infumorph, the pump is indicated for use in patient populations of 22 years and older (adults). For baclofen and 0.9% saline solution, the pump system is indicated for use in patient populations of 12 years and older (adolescents and adults).

Drug Information: See drug labeling for indications, contraindications, warnings, precautions, dosage, administration, screening procedures and under/over dose symptoms and management. Patients should be informed of signs and symptoms that require medical attention.

Contraindications: Implantation is contraindicated in the presence of infection (known or suspected); insufficient body size or anatomy; incompatible spinal anatomy or obstruction of CSF flow; implant depth >2.5cm below skin; allergies to catheter or pump materials; intolerance to implanted devices; medical history of substance abuse deemed to prohibit intrathecal drug administration; occupations with exposure to high current industrial equipment, powerful magnets or transmitting towers; hyperbaric exposure.

Warnings: FAILURE TO EMPTY THE PUMP PRIOR TO EXPOSURE TO MRI ENVIRONMENT COULD RESULT IN DRUG OVERDOSE THAT COULD LEAD TO SERIOUS PATIENT INJURY OR DEATH; THE PUMP MAY NEED TO HAVE AS MUCH AS 20ML OR 40ML OF DRUG REMOVED DEPENDING ON THE PUMP TYPE AND MODEL NUMBER. USE OF UNAPPROVED DRUGS (e.g., DRUG COCKTAILS, PHARMACY COMPOUNDED DRUGS, MORPHINE WITH PRESERVATIVES, ETC.) WITH THE PROMETRA II PUMP COULD RESULT IN PUMP FAILURE AND/OR SERIOUS ADVERSE EVENTS SUCH AS SEVERE UNDERDOSE, OVERDOSE OR DEATH; Prometra System is MRI Conditional- consult the labeling for MRI information. Medical personnel should be familiar with approved drug intended for use with the implanted pump system, including dosing and symptoms related to and treatment for under- or over-dosing.

Precautions: All product instructions should be read prior to use. An inflammatory mass resulting in serious neurological impairment, including paralysis, may occur at tip of catheter. Monitor patients carefully for new neurological signs or symptoms. Monitor patients after pump and/or catheter implant or replacement for signs of underdose/overdose. Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion. Abrupt withdrawal of intrathecal baclofen may be life-threatening. Electromagnetic interference may interfere with Programmer telemetry during pump programming. Pain on injection may be early sign of infection. In the pediatric population, care must be taken to select an appropriate location, taking into consideration available body mass, presence of ostomies, growth development, and comorbidities.

Adverse Events: The potential exists for serious complications. Adverse events include but are not limited to: pocket seroma/hematoma with or without infection, pump site skin erosion, pump rotation/migration/flipping or twisting, adverse reaction to pump materials, granuloma; infection in intrathecal space, including meningitis, nerve damage.

For full prescribing information and full disclosure of contraindications, warnings, precautions, adverse events and MRI Instructions, please call Flowonix at 855-356-9665 and/or consult Flowonix website at Flowonix.com

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