Infusyn is proud to have developed an implantable infusion pump with one-of-a-kind technology. Our team has been committed to helping physicians provide pain relief to those who experience the worse effects of chronic pain – loss of function and decreased quality of life.
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Our goal is to provide healthcare professionals with any information they may need regarding the Prometra II drug delivery system. Information about the clinical trial to show the safety and efficacy of the pump; brochures intended for patient education; product information on Infumorph, the specialty medication used with the Prometra II drug delivery system; indications, safety information, and warnings; information on reimbursement; and instructions for use are all provided.
Please do not hesitate to reach out to the team at Infusyn if you require further information on the Prometra II drug delivery system.
Distrubutors:
Infusyn’s Prometra II® Programmable Pump has been approved by the FDA after a rigorous clinical trial. We have developed a variety of programs to ensure that physicians are provided with the most up-to-date information about this exciting development in intrathecal therapy.
Infusyn has also become involved with many physician organizations in order to strengthen our understanding of the clinical challenges pain management practitioners face. Please contact Infusyn if you would like to learn more about how Prometra II can help your patients.
In January of 2007, a clinical trial was initiated to evaluate the safety, efficacy, and accuracy of the Prometra II® Programmable Pump.
The objective of the study was to determine whether the Prometra II Programmable Implantable Pump System was safe, effective, and accurate for the delivery of preservative-free morphine sulfate approved for intrathecal administration. The study used a non-randomized, open-label, multi-center approach, and enrolled 110 patients from seven investigational sites.
Successful outcomes were benchmarked at industry standards for programmable intrathecal pumps.
Data was to be collected at baseline, monthly for six months, and quarterly after six months. The study illustrated that Prometra II was accurate, safe and effective.
The accuracy of the pump was found to be significantly greater than the industry benchmark of ±14.5%. Further studies will explore what impact a significantly greater accuracy has upon improvement of function and quality of life.
Additionally, we have published multiple papers have been on the programmable infusion system:
In January of 2007, a clinical trial was initiated to evaluate the safety, efficacy, and accuracy of the Prometra II® Programmable Pump.
The objective of the study was to determine whether the Prometra II Programmable Implantable Pump System was safe, effective, and accurate for the delivery of preservative-free morphine sulfate approved for intrathecal administration. The study used a non-randomized, open-label, multi-center approach, and enrolled 110 patients from seven investigational sites.
Successful outcomes were benchmarked at industry standards for programmable intrathecal pumps.
Data was to be collected at baseline, monthly for six months, and quarterly after six months. The study illustrated that Prometra II was accurate, safe and effective.
The accuracy of the pump was found to be significantly greater than the industry benchmark of ±14.5%. Further studies will explore what impact a significantly greater accuracy has upon improvement of function and quality of life.
Additionally, we have published multiple papers have been on the programmable infusion system:
The Prometra II® drug delivery system is a valve gated pump. Instead of rollers and plastic tubing, it uses valves to isolate a titanium dosing chamber from the reservoir and catheter. This results in two principle effects: better control over dosing reliability and longer battery life. Separating the dosing chamber from the reservoir prevents the increase in pressure in the reservoir at refill, decrease in pressure over the weeks as drug is emptied from the reservoir, and from having an impact on the amount of drug delivered. With this design, temperature and pressure effects, like getting into a hot tub or traveling by plane are minimized.
The Prometra II system has incredibly high dependability standards due to the advanced technology used to develop it.
Because no medicine is being absorbed by the body on the way to the spinal cord, the amount of drug typically being delivered by intrathecal pumps per day is very low – often about seven drops of medicine a day. In order to provide high levels of dosing reliability without significant battery power, Prometra II uses a simple micro-valve mechanism to control the flow of medicines from the reservoir to the catheter.
By controlling the flow of medicine with valves in a precision dosing system, Prometra II minimizes weather, atmospheric pressure, reservoir fill level, and medicine flow rate from affecting the accuracy of delivery.
It is customary for patients to undergo an intrathecal drug trial to learn about that particular patient’s level of efficacy and potential side effects of intrathecal drugs before the permanent implantation procedure is scheduled.
No. The Prometra II Pump is reimbursed under the same codes as other programmable, implantable, intrathecal pumps with the same indications. For more information, please see our section on reimbursement and billing guides.
United States Field Safety Notifications
Please note – This page is intended for an audience inside the United States. By continuing to browse you confirm that you are a US resident requesting access to this page or information.
For full prescribing information for both the Prometra II® Programmable Pump and the Prometra II Programmable Pump, please reference the following documents. Both devices are MR Conditional and specific safety protocols for each device are included in the respective IFU.
For more information about Prometra II, contact Infusyn.
United States Field Safety Notifications
Please note – This page is intended for an audience inside the United States. By continuing to browse you confirm that you are a US resident requesting access to this page or information.
For full prescribing information for both the Prometra II® Programmable Pump and the Prometra II Programmable Pump, please reference the following documents. Both devices are MR Conditional and specific safety protocols for each device are included in the respective IFU.
For more information about Prometra II, contact Flowonix.