Stimwave Technologies, a company that develops wireless medical device bioelectronic technology, has received clearance from the US Food and Drug Administration (FDA) for its WaveCrest Mobile iOS Platform patient controllers for opioid-free pain management.
Stimwave said patients with iPhone and Apple Watch will get mobile control over WaveMaster multi-waveform automated programming for the Wireless Freedom Spinal Cord Stimulator (SCS) System for relief from chronic pain.
The Freedom SCS System, the world’s first wireless, fully-programmable SCS neuromodulation device, provides a technological breakthrough for more than 90 million people in the US who endure daily chronic back and leg pain.
Patients can use the WaveCrest Mobile system on iPhone, iPod touch, or Apple Watch to adjust their pain relief therapy.
The first FDA-cleared, easy to use and secure software allows AppleWatch to control a neuromodulation device implanted inside the body. Patients can also use WaveCrest Mobile to fine-tune the power level, visualize battery life, and modify programs pre-programmed by the clinician to control pain without opioids.
Stimwave’s Freedom Stimulators are implanted in an outpatient procedure with any need for general anesthesia, a large surgical incision or a bulky internal battery, significantly reducing the lifetime cost of care for chronic pain patients and offering a safe, viable and effective alternative to opioids.
Clinicians use the Stimwave Freedom System to open an iPad application and program the system using WaveMaster advanced therapy waveforms.
This allows clinicians to provide patients with an array of programming waveforms, frequencies and combinations of options for long-term pain relief, which are selectable from the AppleWatch or iPhone controller.
Stimwave chairman and CEO Laura Tyler Perryman said: “Transformation of pain treatment moving from opioids and pills to interventional solutions like Stimwave can only happen as a result of empowering the masses to take control of their pain, which is now as easy as 1-2-3 with WaveCrest Mobile.”
San Antonio’s Advanced Spine and Pain Center medical director Ellen Lin said: “WaveCrest Mobile provides patients with a high-tech approach to controlling their pain through their mobile device and future features and upgradeability options they never had before.”