Stimwave Technologies won CE Mark approval for its SandShark percutaneous injectable anchor system designed to be used in conjunction with its wireless neurostimulator devices to treat chronic pain, according to its distributor Freedom Neuro BV.
The SandShark anchor system is designed to affix the neurostimulator device once the stimulator has been injected. The system slides down over the device and presses the anchor into the tissue, where it is secured to the stimulator and the stimulator is secured to surrounding tissue to prevent migration.
“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 in customization for patients to manage their pain profiles,” Dr. Bart Billet of Belgium’s AZ Delta hospital group said in a prepared statement.
“The SandShark Percutaneous Injectable Anchor System is a breakthrough for spinal cord stimulators, peripheral nerve stimulators, and all neurostimulation devices. It allows clinicians to inject a stimulator and its anchor through the same needle puncture port, opening the door for more clinicians to more easily provide patients with our highly efficient stimulators,” founder & CEO Laura Perryman said in a press release.
In April, Stimwave Tech said it won a Distribution and Pricing Agreement with the Department of Defense’s Defense Logistics Agency.
Through the 5-year contract, Stimwave will supply the Agency with its Freedom spinal cord stimulation systems. The Ft. Lauderdale, Fla.-based company touted the contract as the 1st global agreement for SCS devices by a US government agency.
