AbĀbott Laboratories is anĀnounĀcing new priĀvate inĀsurĀance covĀerĀage for a novel implantable medĀiĀcal deĀvice to treat neuĀroĀpathĀic pain, a stubĀborn type of pain that can drive paĀtients to long-term oĀpiĀoid use.
The deĀvice, known toĀday as the ProĀclaim DRG neurostimulator, was sold by MinĀneĀsoĀta's St. Jude Medical unĀtil AbĀbott acĀquired the comĀpany in JanĀuĀarĀy 2017. AbĀbott had cited St. Jude's line of neurostimulation deĀvices, inĀcludĀing its DRG stimĀulĀaĀtor, as a key moĀtiĀvaĀtion for buyĀing the comĀpany and bolĀsterĀing its growĀing medĀiĀcal deĀvice theraĀpies.
On TuesĀday, inĀsurĀer Aetna unĀveiled a naĀtionĀal covĀerĀage deĀciĀsion that opens up covĀerĀage for AbĀbott's ProĀclaim DRG neurostimulator, exĀpandĀing acĀcess to the deĀvice for aĀbout 22 milĀlion people in Aetna fully-insured and self-insured plans, AbĀbott said. The deĀvice is also coĀvered by MedĀiĀcare, but othĀer maĀjor priĀvate inĀsurĀers are still evĀaluĀatĀing it for posĀsiĀble covĀerĀage.
"It's enĀcourĀagĀing to see priĀvate payĀers like Aetna reĀview the clinĀiĀcal data and outĀcomes, then choose to proĀvide acĀcess to DRG stimĀuĀlaĀtion for their memĀbers," AbĀbott neuromodulation vice presĀiĀdent Keith Boettiger said in a stateĀment.
The ProĀclaim DRG (preĀviĀousĀly known as the Axium neurostimulator) works by sendĀing mild eĀlecĀtric stimĀuĀlaĀtion to a dense clusĀter of nerves in the spiĀnal colĀumn called a dorĀsal root ganĀgliĀon (DRG). Implantable neurostimulators like the ProĀclaim DRG use eĀlecĀtricĀiĀty to disĀrupt or block the nerve acĀtivĀiĀty that leads to the senĀsaĀtion of chronĀic pain.
Neurostimulators have long been used to stimuĀlate nerves and block pain sigĀnals, but the ProĀclaim DRG is unique in that it tarĀgets a speĀcifĀic clusĀter of neuĀrons at the base of spiĀnal nerves. These DRG strucĀtures transĀmit sigĀnals from senĀsory nerves to the brain, inĀcludĀing real pain sigĀnals and also the chronĀic burnĀing and shootĀing pain that can hapĀpen when nerves or surĀroundĀing tisĀsues are damĀaged.
The U.S. Food and Drug Administration apĀproved the deĀvice in 2016 to aid in the manĀageĀment of modĀerĀate to seĀvere inĀtracĀtaĀble pain of the lowĀer limbs in adults with two forms of comĀplex reĀgionĀal pain synĀdrome, inĀcludĀing peoĀple with conĀfirmed and unĀconĀfirmed nerve inĀjuĀries that cause chronĀic pain. (PaĀtients in the study that led to apĀprovĀal of the deĀvice were elĀiĀgiĀble only afĀter they failed to get reĀlief from at least two drug theraĀpies, and they reĀmained on their pharĀmaĀcoĀlogĀic theraĀpies durĀing the study.)
An Aetna spokesperson on Tuesday referred questions about the coverage policy back to Abbott, whose spokesperson said Aetna's coverage is in line with the FDA's approved indications for the device.
AbĀbott said that exĀtendĀing covĀerĀage of deĀvices like the ProĀclaim DRG supĀports the goals of the FDA and MedĀiĀcare to imĀprove acĀcess to non-oĀpiĀoid alĀterĀnaĀtives for pain manĀageĀment.
As the huĀman toll of the oĀpiĀoid-aĀbuse epiĀdemĀic spreads, medĀiĀcal deĀvice makĀers across the naĀtion have been keen to point out that their theraĀpies do not rely on adĀdicĀtive mediĀcaĀtions to achieve reĀlief. MinĀneĀsoĀta health techĀnolĀoĀgy comĀpanies offer many difĀferĀent non-oĀpiĀoid treatĀments, from conĀtinĀuĀous peĀriphĀerĀal nerve blocks to radio-frequency abĀlaĀtion of nerves.
EĀlecĀtric neuromodulation theraĀpies like the ProĀclaim DRG don't work for evĀerĀyĀone, which is part of the reaĀson why comĀpanies like AbĀbott ofĀfer a noninvasive weekĀlong triĀal deĀvice for a temĀpoĀrary eĀvalĀuĀaĀtion of the techĀnolĀoĀgy, beĀfore committing to getĀting an implantable medĀiĀcal deĀvice.
St. Jude's long-term implantable Axium stimĀulĀaĀtor, which it acĀquired by buyĀing SpiĀnal ModĀuĀlaĀtion, Inc., in 2015, was upĀgradĀed and reĀnamed in 2017 to a new platĀform that alĀlows for BlueĀtooth communication with an iPod Touch paĀtient conĀtrolĀlers and iPad Mini phyĀsiĀcian proĀgramĀmers.
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