Abbott nets FDA approval for 'low-dose' long-term neurostimulator

At its lowest setting, the Proclaim XR implant delivers mild electrical pulses in cycles for 30 seconds on and six minutes off, or about two hours per day. (Abbott)

The FDA has approved a new “low-dose” version of Abbott’s spinal cord neurostimulation system, designed to treat people with chronic pain for up to 10 years without recharging.

The Proclaim XR system uses patterned, mild bursts of electricity to alter pain signals as they travel along nerves to the brain. The low-strength pulses help extend the implants' battery life while mimicking the natural patterns found in the central nervous system, according to the company.

The lowest effective dose is determined and programmed by a clinician, while the device itself can be paired with Apple devices over Bluetooth, so users can help manage their pain.  

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“Recharge-free means patients can live their lives without the constant reminder of being in treatment," Keith Boettiger, vice president of Abbott's neuromodulation business, said in a statement. "This is a meaningful advancement for the millions of people who need new options when it comes to managing the effects of their chronic pain.”

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In a clinical study, the 24 enrolled patients all saw pain relief with less than six hours of battery use per day. About half reported relief with the lowest setting—which cycles for 30 seconds on and six minutes off, amounting to about two hours of battery time each day. 

Currently, the system is under review for a CE mark.

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