Stimwave receives CE mark approval for Freedom-8A spinal cord stimulation system


Stimwave Neuro LP has announced CE mark approval for 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. This is the first of its kind on the global market.

According to Stimwave, its CE marked Freedom-8A SCS System can provide European 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,” says Jean-Pierre Van Buyten, director of the Multidisciplinary Pain Centre, AZ Nikolaas of 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.”

According to a press release, the system eliminates the long wires painfully tunnelled through the body and connected to the 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.

“Now people in pain will be able to utilise one system, with all features, that we can inject easily in a minimally-invasive procedure and allows them to have an MRI anytime,” says Frank de Loos, head of the Pain Department at Amphia Hospital and CEO and Founder of StimClinics. “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.”