Saluda Medical’s Evoke Spinal Cord Stimulation System Approved

Australia-based Saluda Medical has received the FDA’s premarket approval for its Evoke spinal cord stimulation system.

The device is indicated to treat chronic pain of the trunk or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

The system assesses the nerves’ response to stimulation and can provide “continually optimized therapy,” the company says. It can also record millions of data points per day for clinical use.