Stimwave Receives Freedom-8A SCS FDA Clearance

Stimwave Receives Freedom-8A SCS FDA Clearance

Stimwave Receives FDA Clearance and Launches Commercialization for World’s Smallest Fully-Programmable, Eight-Electrode Wireless Pain Relief SCS System

 

FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–Stimwave Technologies, a leading innovator in wireless medical device technology, a manufacturer and an independent research institute headquartered in Fort Lauderdale, Florida, today announced that it has received FDA clearance to market its eight-electrode wireless, micro-technology neuromodulation device for relief of chronic back and leg pain. The Stimwave Freedom-8A Spinal Cord Stimulation (SCS) System is the world’s first wireless, fully-programmable SCS neuromodulation device available and presents a potentially life-changing technological breakthrough for the more than 90 million people in the United States who endure daily chronic back and leg pain. Stimwave has also begun commercialization of the device and began implanting in the first patients earlier this quarter. Full nationwide commercialization is planned for the first of the year.

“This advancement will provide clinicians with a multitude of options and allow patients the most amount of freedom over their pain management.”

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Early marketing surveys conducted by the Company show that the majority of candidate patients would prefer a wireless, miniature device to the conventional, larger wired systems, which are typically 40 cc in volume compared to the 0.4 cc volume of the Freedom Stimulator device.

“Patients utilizing the Stimwave Freedom-8A and Freedom-4A products not only have the option of a wireless device, but the recent advancements in this technology’s platform also provide the majority of the programming and placement features available from wired systems that are 95 percent larger,” said Stimwave Chairman and CEO Laura Tyler Perryman. “The safety and efficacy of even wider programmability options, or high-frequency programming up to 10,000 Hz, is currently being investigated with an FDA approved clinical trial.”

The wireless device’s form factor represents a major breakthrough in the field of neuromodulation and eliminates the need for painful extensive tunneling and placement of internal batteries within the body. Stimwave’s Freedom-8A Stimulator is implanted in an outpatient procedure through a standard needle with no need for general anesthesia or a large surgical incision. The approach is expected to significantly reduce the lifetime cost of care for chronic pain patients and offer a safe, viable and effective alternative to pain medications.

“Patients’ needs in pain management are complex and unique. The Freedom-8A SCS System is a first-of-its-kind product and offers a wide variety of advanced programming features, polarity selection options for up to eight separate electrodes per device, in the body in the least invasive fashion ever offered,” said Dr. David Kloth, M.D., medical director of the Connecticut Pain Care Center and author of Pain Wise. “This advancement will provide clinicians with a multitude of options and allow patients the most amount of freedom over their pain management.”

The technology leverages a tiny, state-of-the-art device that delivers small pulses of energy, in a fully-selectable manner, to eight electrodes placed near surrounding nerves, triggering a reaction that enables the brain to remap specific pain signals, thus providing pain relief. The Stimwave Freedom Spinal Cord Stimulation (SCS) System received FDA clearance for its four-electrode device last year, which has also been upgraded to a fully-programmable model.

Please visit www.stimwave.com for more information on the availability of the Stimwave Freedom-8A SCS System. The Stimwave Freedom High Frequency (HF) SCS System is not approved for sale or commercial distribution, and is limited to investigational use only. For more information about the Stimwave High Frequency (HF) clinical trial, please visit www.clinicaltrials.gov.

 

Contacts

Glodow Nead Communications
Jenna Hudson, Sonia Sparks and Evan Nicholson, 415-394-6500
StimwavePR@GlodowNead.com