Peripheral nerve stimulation for amputee pain

AbstractThe goal of the presently proposed Commercialization Readiness PilotCRPProgram project is to prepare for commercialization of an implantable systemdeveloped in Phase IIthat is capable of delivering a novel peripheral nerve stimulationPNStherapy shown to be highly effective in treating intractable pain in a majority of amputees in previous studiesincluding Phase IApproximatelymillion individuals in the U Sare living with an amputationand aboutindividuals undergo an amputation each yearPostamputation pain has a high incidenceand frequently causes further disabilitydepressionand reductions in quality of lifeExisting long term pain therapies are inadequate long term and are expensivetotaling up to $Billion year in the U SThe previous Phase I project successfully demonstrated the feasibility of relieving post amputation pain inof subjects during in clinic testing with a method of peripheral nerve stimulationPNSthat selectively activates target fibers using a single electrode inserted remote from the nerveIn an additionalwk home trial of temporary percutaneous stimulationall subjects that completed the trial experienced clinically significant pain reliefaveragewhile receivinghr day stimulationconfirming that pain relief can be sustained as long as stimulation is deliveredThe Phase II project is in the final year of the early stage development of an implantable pulse generatorIPGdesigned to be capable of delivering the novel PNS therapy long term for post amputation pain reliefThe therapy is designed to use a flexibleself anchoring electrode that avoids the need for open surgery and precise lead placementand minimizes the risk of complicationsfracture andampmigrationthat previously limited use of existing PNS systemsThese risks are further reduced by an IPG that is sufficiently thin to be placed in the residual limbeliminating the need for the lead to cross the hip joint and avoiding the repeated flexing and bending that frequently causes failures with existing commercial systemsThe proposed CRP project is needed to advance the system from an early stagePhase IIto its final latestagecommercialdesign to enable rapid clinical adoption among pain physicians by enhancing the system implantation toolsAimto reduce complexity and the need for support staffwhile leveraging a familiar procedural approach in which the vast majority of these physicians are already proficientThe project is also needed to advance system production from early stageintended in the Phase II project for low volumes in which each IPG is manufactured by skilled technicians in a time intensive processto late stage development of sustainablequality controlledhigh volume production in line with Good Manufacturing PracticesGMPto enable successful commercializationEach aim will be considered successful if all verification validation tests are passedIf successfulthe final product will have the potential to meet the needs of amputees and their physicians through a commercially viable and sustainable therapy following FDA approval Project NarrativeApproximatelymillion persons in the United States are living with amputationsand almost all have post amputation painwhich is often severe and leads to disabilitydepressionand general sufferingPost amputation pain can greatly reduce quality of life and interfere with the simple activities of daily livingbut none of the present treatment options are adequate in managing the painThe goal of this project is to complete late stage development of a system designed to deliver a novel electrical stimulation therapyreduce post amputation painimprove pain disabilityand increase quality of life