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Stimwave Announces Regulatory Approval from Australian Therapeutic Goods Administration (TGA) for its Freedom Spinal Cord Stimulation System

April 7, 2017

Stimwave LLC, a medical device manufacturer and independent research institute headquartered in South Florida, today announced regulatory approval from the Australian Therapeutic Goods Administration (TGA) for its Freedom Spinal Cord Stimulation (SCS) System.

Stimwave will be launching the product today in Australia at the Neuromodulation Society of Australia and New Zealand 12th Annual Scientific Meeting in Adelaide, South Australia marketed through its subsidiary Stimwave Medical Pty Ltd.

Stimwave notes 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 drastically smaller stimulator (0.4cc volume) and a truly minimally invasive procedure, which eliminates the need for large surgical incisions or general anesthesia.

One in three Australians over 65 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,” said 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.

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