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

VERITAS Vision System Is Introduced by Johnson & Johnson

The company will offer live demos of the new system in a wet lab at the Johnson & Johnson booth (#2813) this weekend at the 2021 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting.

GenesisCare Orders 27 Elekta Flexitron Treatment Devices

"GenesisCare continues to demonstrate its commitment to improving patient outcomes worldwide and Elekta is delighted to play a vital partnering role to achieve this mission," said Gustaf Salford, Elekta's President and CEO.

FoodMarble AIRE Shown to Exceed the Performance of ‘Gold Standard’ SIBO Testing in Clinical Trial

SIBO is a very common disorder where there are excessive bacteria present in the small intestine. The true prevalence of SIBO in the general population is largely unknown, with some studies estimating its occurrence in up to 15% of healthy individuals. It is also largely associated with many other common clinical conditions, including irritable bowel syndrome, where 40-80% of IBS patients have SIBO.

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 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.



Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.