PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM FLOWONIX MEDICAL, INC.
ABOUT MANUFACTURER
Flowonix as a company is involved in the pain management and relief community and provide support to physician education. Flowonix continue to invest in technology to allow patients to live their lives. Flowonix has developed an implantable drug delivery system which is designed to deliver drugs into the spinal cord. With a goal to relieve patients from a variety of chronic disorders Flowonix works to help patients return to normal lives. Flowonix continues to be involved in research and development and to update information regarding the Prometra® drug delivery system. (1)
Get Help With Your Nursing Essay
If you need assistance with writing your nursing essay, our professional nursing essay writing service is here to help!
PURPOSE FOR SELECTION OF PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
The Prometra drug delivery system is a novel device which consists of a Pump which can inject drugs in to Intrathecal space. This device was an excellent success and was approved through Pre-Market Authorization Pathway by FDA. The device is being marketed since 2012 and focuses on the accuracy of the drug delivery into the spinal cord. This device was having a long stable marketing history and was approved with help of a clinical trial. The device consists of a drug part as well as a remote control and has a wide application and had a complex regulatory pathway to approval.
INTRODUCTION
The Prometra Programmable Pump is designed to provide controlled delivery of Infumorph to the intrathecal space via the separately supplied Intrathecal Catheter. The Prometra Programmer is a separately supplied handheld, menu-driven device that enables remote programming of the Prometra Pump. (7)
System functions (e.g., dosing) are controlled by an external hand-held, battery-operated programmer. Device contains a metal bellows drug reservoir having a capacity of 20 milliliters (mL). The reservoir propellant is stored within the rigid housing and provides the driving pressure for the pump. The driving pressure on the reservoir forces the infumorph through an outlet filter which has a 0.22 pm range. The Infumorph (drug) is pumped into an electronically controlled flow metering valve-accumulator subsystem. The Infumorph passes from the flow metering subsystem, into the catheter access port then into the catheter for delivery to the intrathecal space. (6)
It is different from the peristaltic pump as Prometra consists of a valve which regulates the flow. Instead of rollers and plastics tubing, Prometra uses valves to isolate a titanium dosing chamber from the drug storage and the catheter.These results in the accurate dosing and better battery life. (8)
INTENDED USE
The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP). (6)
COMPONENTS
The Prometra Implantable Pump components consist of the following devices:
* Prometra Programmable Pump
* Intrathecal Catheter
The Prometra Implantable Pump accessories consist of the following:
* Prometra Programmer
* Tunneler
* Refill Kit
* Catheter Access Port (CAP) Kit
MARKETING HISTORY and MAJOR CHANGES
In January of 2007, Flowonix began a clinical trial to evaluate the safety, efficacy, and accuracy of the Prometra® Programmable Pump. The objective of the study was to determine whether the Prometra 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. (2)
The Prometra Programmable Pump was approved by FDA on 13th February 2012. The approval was received via PMA pathway. The FDA has requested the manufacturer to perform the post-approval studies (A prospective, non-randomized, open-label, multicenter study to evaluate the long-term safety of the Prometra Programmable Pump System) which was performed at 30 centers in US and on 400 patients out of which 300 were followed up to 5 years. (4)
The device received approval for a new version called Prometra II system. The approval was granted in 18 December 2014. The most significant advancement associated with the Prometra II drug infusion device was the flow-activated safety valve (FAV™), which allowed patients to have an MRI without the necessity of drug removal prior to the procedure. (3)
On 10 Feb 2015 the approval for new programmer device was obtained and was to be marketed under the trade name Prometra Programmable Infusion Pump System and is indicated for Intrathecal Infusion of Infumorph (preservative-free morphine sulfate) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP). Recently, this device was approved to be used with Baclofen Injection, Intrathecal 500-2000 mcg/ml). (5)
A total 60 supplements are done till date for varied reasons like change in vendor to the software revisions including the new advancements done to the pump. (5)
PRODUCT RECALLS:
A total of 6 recalls were initiated by the manufacturer since the approval of the device. One Recall was initiated in 2017 for an overdose AE while the remaining 5 recalls were initiated in June 2019 for a software problem. All 6 of the recalls were classified as Class 2 by FDA.
Details of the recalls are as follows:
|
Sr. No. |
Recall Number |
Date of Posting |
Reason |
|
1 |
Z-2740-2017 |
06/19/2017 |
Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump has an FDA-approved design feature intended to permit safe exposure to an MRI without removing drug from the reservoir. |
|
2 |
Z-1712-2019 |
06/03/2019 |
The pump shuts down unexpectedly if the Error 115is shown, an alarm associated with a watchdog timer timeout, is triggered. There was an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped. |
|
3 |
Z-1713-2019 |
06/03/2019 |
|
|
4 |
Z-1714-2019 |
06/03/2019 |
|
|
5 |
Z-1715-2019 |
06/03/2019 |
|
|
6 |
Z-1716-2019 |
06/03/2019 |
Source: (PMA Database)
REFERENCES:
- Flowonix Inc. (n.d.). News and Information. Retrieved from Flowonix.com: https://flowonix.com/healthcare-provider/about-flowonix/news-information
- Flowonix Inc. (n.d.). Publications and Clinical Study. Retrieved from Flowonix.com: https://flowonix.com/healthcare-provider/resources/publications-clinical-study
- Flowonix Medical Inc. (n.d.). Flowonix Medical Inc. Announces FDA PMA(S) Approval of Prometra II. Retrieved from PR Newswire: https://www.prnewswire.com/news-releases/flowonix-medical-inc-announces-fda-pmas-approval-of-prometra-ii-300022126.html
- Food and Drugs Administration. (n.d.). Approval Order. Retrieved from Food and Drugs Administration: https://www.accessdata.fda.gov/cdrh_docs/pdf8/P080012A.pdf
- Food and Drugs Administration. (n.d.). PMA Database. Retrieved from Food and Drugs Administration: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080012
- Food and Drugs Administration. (n.d.). Summary of Safety and Effectiveness Data. Retrieved from Food and Drug Administration - PMA database: https://www.accessdata.fda.gov/cdrh_docs/pdf8/P080012B.pdf
- Medasys. (n.d.). Medasys - Patient Guide. Retrieved from Food and Drug Administration - PMA database: https://www.accessdata.fda.gov/cdrh_docs/pdf8/P080012C.pdf
- Flowonix Inc. (n.d.). Frequently Asked Questions. Retrieved from Flowonix.com: https://flowonix.com/healthcare-provider/resources/faqs
Cite This Work
To export a reference to this article please select a referencing style below:
