Long-term follow-up of a novel implantable programmable infusion pump.
OBJECTIVE
The Prometra® Programmable Pump System (Flowonix Medical, Inc., Mt. Olive, NJ, USA) is designed for continuous intrathecal administration of morphine sulfate to treat chronic intractable pain. As a follow-up to a previous report on acute six-month data, this study evaluated the efficacy of treatment at one year and the accuracy of drug delivery throughout the study (average of 2.5 years, range 0-3.6 years).


METHODS
Accuracy of drug delivery was determined as the ratio of delivered-to-programmed drug volume at scheduled refill visits (monthly for the first six months and every three months thereafter). Efficacy was assessed at 12 months using the visual analog and numeric rating scales and the Oswestry Disability Index. Safety was assessed by documenting adverse events and device complications throughout the study.


RESULTS
The mean accuracy of the Prometra pump was 97.9% and was comparable to the reported accuracy at one to six months (97.1%). After 12 months, 68% of the remaining subjects reported improvement in disability scores from baseline and more than 75% of the remaining subjects reported decreases in pain from baseline. The incidence rates of adverse events and device complications were similar to previous reports for this therapy.


CONCLUSIONS
The Prometra pump demonstrated accurate drug delivery throughout the study and provides an effective and safe means for intrathecal administration of morphine sulfate for treatment of chronic intractable pain.
Wake Forest University Health Sciences, Winston-Salem, NC, USA. rrauck@ccrpain.com
Richard
R
Rauck
Timothy
T
Deer
Steven
S
Rosen
Gurpreet
G
Padda
John
J
Barsa
Elmer
E
Dunbar
Gopala
G
Dwarakanath
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015918:Infusion Pumps, Implantable; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage*; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D011446:Prospective Studies; D016896:Treatment Outcome
D000701:Analgesics, Opioid; D009020:Morphine