Tele: 561.316.3330
Breaking Medical Device News

Monday, October 18, 2021
HomeStimwaveStimwave Announces Regulatory Approval from Australian Therapeutic Goods Administration (TGA) for its...

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.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Insulet Announces Board of Director Changes with Appointment of Luciana Borio, M.D. and Retirement of Sally W. Crawford

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced...

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

By using this website you agree to accept Medical Device News Magazine Privacy Policy