HFX iQ IPG Kit (NIPG3000) - Analgesic spinal cord electrical stimulation system pulse generator implantable

Intended purpose

The HFX iQ System and HFX Trial System are devices intended to provide stimulation therapy to the spinal cord through implanted leads. They are indicated as aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain. The HFX iQ System and HFX Trial System, when programmed to include a frequency of 10 kHz, are indicated as aids in the management of chronic intractable pain of the lower limbs, including unilateral or bilateral pain, associated with diabetic neuropathy. The HFX iQ System and HFX Trial System, when programmed to include a frequency of 10 kHz, are indicated as aids in the management of non-surgical refractory back pain (intractable back pain without prior surgery and not a candidate for back surgery).

Functional description

The Nevro Senza HFX iQ IPG is a rechargeable implantable device with 16 output channels capable of stimulating the spinal cord nerves through electrode leads. The IPG header contains the charging coil and two ports to allow the insertion of leads. The rechargeable battery is contained in a hermetically sealed housing, which is inside the HFX iQ IPG Titanium enclosure. The kit contains the IPG and accessories used during the surgical (implantation) procedure.