Stimwave Technologies Gets CE Mark for SCS System

Stimwave Technologies Inc. has earned the CE mark for its Stimwave Freedom spinal cord stimulation (SCS) system. Stimwave Freedom is a wireless programmable neuromodulation device with up to eight electrodes that can be introduced through a needle without surgery for relief of chronic back and leg pain.

More than 400 million people worldwide endure daily chronic pain. The Stimwave Freedom, which will be marketed in Europe, can provide patients with up to 64 electrode contacts, offer traditional programming options, as well as other programming options including frequencies up to 10,000 Hz or waveform customization. The Freedom-8A SCS system with eight electrodes continues to utilize the Apple iPad programmer, leveraging Bluetooth protocols for ease of use in programming the variety of options.

“A wireless system that enables clinicians to actually have the full programming capabilities of IPGs, all in a device that can be injected, represents a paradigm shift in the field of options to provide the best of breed in customization for patients to manage their pain profile,” said Jean-Pierre Van Buyten, M.D., director of the AZ Nikolaas Multidisciplinary Pain Centre in Belgium. “The ability of the CE Marked Freedom-8A SCS System to offer a variety of stimulation programs, advance algorithm options, as well as 1.5 or 3T MRI scans, gives clinicians all the options they need without having to switch manufacturers. This is an all-in-one option, and the wireless injectable feature is what patients are glad for.”

The system eliminates the long wires painfully tunneled through the body and connected to the battery source (a pacemaker-like device), called an IPG, offered by traditional products. With the Stimwave technology, only a small device with electrode contacts and an embedded chip is placed within the body through a needle, shortening the time required for the minimally-invasive, outpatient procedure, and enabling a potentially lower-cost option for the European market. The Freedom-8A SCS System allows the European patient to have a whole body 3T or 1.5T MRI without removing the implant. With other systems, the patient is limited to certain body parts and cannot have a 3T scan, which is the standard of care for cancer scanning and for many orthopedic procedures.

“Now people in pain will be able to utilize one system, with all features, that we can inject easily in a minimally-invasive procedure and allows them to have an MRI anytime,” said Frank de Loos, M.D., head of the pain department at Amphia Hospital. “Previously, we had to remove systems to give an MRI and also replace systems for IPGs that fail often. This system will make long-term patient care better. In Europe, we also eliminate the trial phase, because the full system is implanted in one visit, which is unique to the Stimwave European offering.”

Stimwave makes wirelessly powered, injectable, microtechnology neurostimulators.