Australian Therapeutic Goods Administration approves Freedom spinal cord stimulation system

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The Australian Therapeutic Goods Administration (TGA) has granted regulatory approval for the Freedom Spinal Cord Stimulation (SCS) System (Stimwave). The company launched the product in Australia at the Neuromodulation Society of Australia and New Zealand 12th Annual Scientific Meeting (8–9 April, Adelaide, Australia).

The Freedom SCS System is the world’s first wireless, fully programmable neuromodulation device intended for the treatment of chronic, intractable pain of the back or legs. The novel technology allows for a smaller stimulator (0.4cc volume) and a minimally invasive procedure, which eliminates the need for large surgical incisions or general anaesthesia.

One in three Australians over 65 years old lives with chronic pain and goes vastly under-treated, according to reports from PainAustralia.org. Some chronic pain conditions suitable for SCS treatment include failed back surgery syndrome, neuropathic pain secondary to peripheral nerve lesion, radicular pain, peripheral neuropathic pain caused by trauma, or even complex regional pain syndrome.

“This device unlocks so many more options for placement approaches and programming that were never possible before with wired systems,” says Laura Tyler Perryman, co-founder and chairman of Stimwave. “With the Freedom System, we are able to better detail each patient’s therapy and address their pain.”

The technology consists of placing electrodes near the painful nerve area and delivering small pulses of energy that blocks pain signals before they reach the brain. The Freedom SCS System is also approved in European Union countries, the United States, and Canada.