According to a market research study from Neurotech Reports, the worldwide neuromodulation device industry is expected to grow from more than $6 billion in 2014 to over $10 billion in 2018. The market for implanted spinal stimulators used to treat chronic pain alone is valued at $1.80 billion worldwide for 2014 and is expected to grow to $2.88 billion in 2018.
A new product by Stimwave Technologies will add to this growing market. The company which is headquartered in Miami Beach, Florida, received FDA approval for their Freedom Spinal Cord Stimulation System on December 2. The device is indicated for relief of chronic back and leg pain.
Spinal cord stimulators (SCS), or neuromodulation devices, act directly on the nerves by delivering electrical or pharmaceutical agents to a target area. Since the introduction of this technology in the 1960s, many advances have been made, including smaller and more easily implanted devices. Traditional SCS devices include an implantable generator, leads and a programmer.
Usually, the implantation of these devices require an open procedure by a surgeon but the Freedom SCS System can be injected with a standard 14G Tuohy needle. This makes the Freedom system the world’s first injectable, wireless neuromodulation device. Also, unlike traditional devices, the Freedom SCS does not require a generator. The electrode or wire contains the stimulator which is powered by a transmitter (wearable antenna assembly) and worn by the patient. Since the internal device does not contain batteries, they don’t have to be replaced.
The Freedom SCS System is set to be available in the US market as early as January 2015. This will be a direct competitor to the implantable SCS devices currently available from Medtronic, Boston Scientific and St. Jude.