Ab­bott Laboratories is an­noun­cing new pri­vate in­sur­ance cov­er­age for a novel implantable med­i­cal de­vice to treat neu­ro­path­ic pain, a stub­born type of pain that can drive pa­tients to long-term o­pi­oid use.

The de­vice, known to­day as the Pro­claim DRG neurostimulator, was sold by Min­ne­so­ta's St. Jude Medical un­til Ab­bott ac­quired the com­pany in Jan­u­ar­y 2017. Ab­bott had cited St. Jude's line of neurostimulation de­vices, in­clud­ing its DRG stim­ul­a­tor, as a key mo­ti­va­tion for buy­ing the com­pany and bol­ster­ing its grow­ing med­i­cal de­vice thera­pies.

On Tues­day, in­sur­er Aetna un­veiled a na­tion­al cov­er­age de­ci­sion that opens up cov­er­age for Ab­bott's Pro­claim DRG neurostimulator, ex­pand­ing ac­cess to the de­vice for a­bout 22 mil­lion people in Aetna fully-insured and self-insured plans, Ab­bott said. The de­vice is also co­vered by Med­i­care, but oth­er ma­jor pri­vate in­sur­ers are still ev­alu­at­ing it for pos­si­ble cov­er­age.

"It's en­cour­ag­ing to see pri­vate pay­ers like Aetna re­view the clin­i­cal data and out­comes, then choose to pro­vide ac­cess to DRG stim­u­la­tion for their mem­bers," Ab­bott neuromodulation vice pres­i­dent Keith Boettiger said in a state­ment.

The Pro­claim DRG (pre­vi­ous­ly known as the Axium neurostimulator) works by send­ing mild e­lec­tric stim­u­la­tion to a dense clus­ter of nerves in the spi­nal col­umn called a dor­sal root gan­gli­on (DRG). Implantable neurostimulators like the Pro­claim DRG use e­lec­tric­i­ty to dis­rupt or block the nerve ac­tiv­i­ty that leads to the sen­sa­tion of chron­ic pain.

Neurostimulators have long been used to stimu­late nerves and block pain sig­nals, but the Pro­claim DRG is unique in that it tar­gets a spe­cif­ic clus­ter of neu­rons at the base of spi­nal nerves. These DRG struc­tures trans­mit sig­nals from sen­sory nerves to the brain, in­clud­ing real pain sig­nals and also the chron­ic burn­ing and shoot­ing pain that can hap­pen when nerves or sur­round­ing tis­sues are dam­aged.

The U.S. Food and Drug Administration ap­proved the de­vice in 2016 to aid in the man­age­ment of mod­er­ate to se­vere in­trac­ta­ble pain of the low­er limbs in adults with two forms of com­plex re­gion­al pain syn­drome, in­clud­ing peo­ple with con­firmed and un­con­firmed nerve in­ju­ries that cause chron­ic pain. (Pa­tients in the study that led to ap­prov­al of the de­vice were el­i­gi­ble only af­ter they failed to get re­lief from at least two drug thera­pies, and they re­mained on their phar­ma­co­log­ic thera­pies dur­ing 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.

Ab­bott said that ex­tend­ing cov­er­age of de­vices like the Pro­claim DRG sup­ports the goals of the FDA and Med­i­care to im­prove ac­cess to non-o­pi­oid al­ter­na­tives for pain man­age­ment.

As the hu­man toll of the o­pi­oid-a­buse epi­dem­ic spreads, med­i­cal de­vice mak­ers across the na­tion have been keen to point out that their thera­pies do not rely on ad­dic­tive medi­ca­tions to achieve re­lief. Min­ne­so­ta health tech­nol­o­gy com­panies offer many dif­fer­ent non-o­pi­oid treat­ments, from con­tin­u­ous pe­riph­er­al nerve blocks to radio-frequency ab­la­tion of nerves.

E­lec­tric neuromodulation thera­pies like the Pro­claim DRG don't work for ev­er­y­one, which is part of the rea­son why com­panies like Ab­bott of­fer a noninvasive week­long tri­al de­vice for a tem­po­rary e­val­u­a­tion of the tech­nol­o­gy, be­fore committing to get­ting an implantable med­i­cal de­vice.

St. Jude's long-term implantable Axium stim­ul­a­tor, which it ac­quired by buy­ing Spi­nal Mod­u­la­tion, Inc., in 2015, was up­grad­ed and re­named in 2017 to a new plat­form that al­lows for Blue­tooth communication with an iPod Touch pa­tient con­trol­lers and iPad Mini phy­si­cian pro­gram­mers.

Joe Carl­son • 612-673-4779