Prometra® II Pump Review
The Flowonix Prometra® II Pump is an innovate device which administers pain-relief medication (Infumorph®) into the body and is designed for patients suffering with chronic pain who have had no success with other, more traditional methods of pain management. The pump is surgically implanted just under the skin and contains the drug Infumorph® which is then automatically administered directly into the spine to reduce the sensation of pain, you are also supplied with a remote control which you can control and personalise to your own dosage. Aside from the pain-relief, the key positives of the Prometra® II Pump is that it features a longer battery life than its competitors, offering a minimum battery life of 10 years which will mean fewer pump replacement surgeries and less chance of infection.
Research has proved* a long-term decrease in pain from the ongoing administration of the pain relief drug Infumorph®, which the Prometra® II Pump administers. The study was conducted with 154 patients over 12 months and saw a major decrease in pain from patients suffering with chronic pain, showing a decrease in pain by -3.2% after 3 months, -29% after 6 months and -70.1% after 3 months.
*Pain Medicine, Volume 14, Issue 6, 1 June 2013, Pages 865–873
The reason for the Prometra® II Pump and Infumorph®’s effective pain relief is because the drug is administered directly into the spinal cord which is the main pathway for information connecting your brain, which in-turn signals the rest of the nerves in the body and makes you feel the sensation of ‘pain’. Standard pain relief medication is taken orally, which of course has a much harder time reaching the spinal cord, since by the time it reaches your spine the body has absorbed most of the drug. The Prometra® II delivers Infumorph® directly into the spinal cord which reduces the amount of medication needed and acts as a pain relief much quicker. Published studies* actually prove that you can take 1/100th of pain medication when it is delivered into the fluid-filled space around your spinal cord (intrathecal space) which is why the Prometra® II is so small and can be surgically implanted into the body since it doesn’t have to carry much load.
*Rauck R, Intrathecal drug delivery. Seminars in Pain Medicine, 2004; 2(1): 2-7
Many patients worry about relying on an implant to automatically administer the correct dosage, but it really isn’t a worry with the Prometra® II. Studies carried out by Flownix themselves* prove the accuracy of the pain relief medication dosage administered by the pump (in relation to what the patient chose via the remote control) to be constantly greater than 95% over 1,730 refills. In regards to longevity of the device accuracy, after 2.5 years of using the Flowonix Prometra® II Pump, accuracy of the dosage administered not only remained above industry standards, but also improved over time between 95.9 – 97.7%! This currently the highest accuracy for a pain medication pump seen on the market to-date.
Another concern tends to be the accuracy of the dosage administered as the reservoir volume drops, however all reviews prove that even as the reservoir holding the pain relief medication decreased, it had no effect of the Prometra®’s drug accuracy. This simply shows that Prometra® provides an accurate flow of drug delivery throughout the dosing-cycle from refill to refill.
* The Prometra’s Utilization in Mitigating Pain (PUMP), conducted under a US FDA IDE (G060192)
During the core study, 110 patients were successfully implanted with the Prometra® II Pump without any pump failures and no granulomas (mass of tissue, typically produced in response to the presence of a foreign substance) were observed during the entire study. Also there were no unanticipated adverse device effects or deaths attributed to the Prometra® pump system.
Many patients worry about an implant reducing their movement when bending or stretching, however the Prometra® II Pump has been designed with a flexible pump stem and features a “sutureless” connection catheter lock which can resist over one pound of pull-out force! This just goes to show how well the implant has been designed and research showed that of all the 110 patients who were assessed during the clinical trial, there wasn’t a single catheter disconnection.
To review a final aspect of the Prometra® II Pump it’s simply worth taking a look at a like-for-like comparison of statistics from a competitor pain-relief pump on the market and see just how innovative Flowonix have made their Prometra® II Pump.
|Prometra II||Synchromed II|
|Longevity||Minimum 10 years (at 0.25 ml/day)||4 – 7 years|
|Warranty||2 year pump warranty
2 year battery warranty
|2 year pump warranty
No battery warranty
|Flow Rate||0.0 – 28.8 ml/day||0.048 – 24 ml/day|
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