In the last thirty days, two new spinal cord stimulation (SCS) devices have come to market. St Jude Medical (NYSE: STJ) announced its FDA approval of the Proclaim Elite SCS system in November, billing at as recharge-free, upgradable system. Neuromodulation newcomer, Nuvectra, announced its Algovita SCS system gained FDA approval in December, highlighting its 24 independent current sources.
And now, another newcomer has an announcement, and it’s an eye opener.
Stimwave Technologies, announced that it has received FDA clearance to market the Freedom-8A Spinal Cord Stimulation (SCS) System, which it says is the world’s first wireless, fully-programmable SCS neuromodulation device.
“The Freedom-8A SCS System is a first-of-its-kind product and offers a wide variety of advanced programming features 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 in a press release.
The wireless device represents a potential breakthrough in neuromodulation because it eliminates the need for surgical tunneling and placement of internal batteries within the body. Instead, it is implanted through a standard needle, which eliminates the need for general anesthesia.
“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.
This last summer, a study published in Anesthesiology, showed that 10,000 Hz high frequency spinal cord stimulation – a feature of another relatively new player in the market, Nevro’s Senza HF10 SCS system – is almost twice as effective as low frequency stimulation for treating back pain.
It looks like Stimwave is looking to offer the same type of stimulation.
“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,” said Perryman.
SCS therapy is used by about 400,000 people to treat back and leg pain. SCS is also known as nerve stimulation, and involves having a small pulse generator placed in the body which produces electrical signals to mask the perception of pain traveling from the painful area to the brain.
One advantage of SCS therapy is that it can be tested out before surgical implantation – called a trial. The trial involves a minor surgical procedure to place a lead along the spinal column that is attached to a temporary stimulator worn outside the body. The trial usually lasts about a week and allows prospective patients to experience the feeling of the therapy, including the level of pain relief it provides.