Stimwave receives FDA clearance for first Wireless SCS System with iPhone-iWatch patient controllers for opioid free pain management

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Stimwave Technologies has announced that it has received US Food and Drug Administration (FDA) clearance for the WaveCrest Mobile iOS platform patient controllers for opioid free pain management. This new system now gives patients iPhone and Apple Watch mobile control over WaveMaster multi-waveform automated programming for the Wireless Freedom Spinal Cord Stimulator (SCS) system for relief of chronic pain. The Freedom SCS System is the first wireless, fully-programmable SCS neuromodulation device providing a life-changing technological breakthrough for the more than 90 million people in the USA who endure daily chronic back and leg pain.

WaveCrest Mobile allows a patient to use an iPhone, iPod touch, or an Apple Watch to adjust their pain relief therapy. This is the first FDA-cleared software that allows the Apple Watch to control a neuromodulation device implanted inside the body. The software is designed to be easy to use and secure. WaveCrest Mobile enables pain sufferers to fine-tune the power level, visualise battery life, and modify programmes that were pre-programmed by their clinician to control pain without opioids.

“Pain suffers are rapidly migrating to the Stimwave Freedom wireless pain relief system as an opioid free option to control their pain- and now they can adjust their therapy with the swipe of their finger through their Apple Watch or iPhone/iPod Touch discretely any time as needed,” said Stimwave chairman and CEO Laura Tyler Perryman. “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.”

Stimwave’s Freedom Stimulators are implanted in an outpatient procedure with no need for general anaesthesia, a large surgical incision or a bulky internal battery known to lead to numerous complications from other legacy older technologies. These products are expected to significantly reduce the lifetime cost of care for chronic pain patients and offer a safe, viable and effective alternative to opioids.

“Patients’ needs in pain management are unique and customised programming is a must. The Freedom System not only is the smallest option available for patients—eliminating the complexities of an implanted lithium ion battery—but offers a wide variety of advanced programming features that the patient can choose through their mobile device,” said Ellen Lin, medical director of San Antonio’s Advanced Spine and Pain Center. “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.”

Utilising the Stimwave Freedom System, clinicians utilise an iPad application to easily program the system using WaveMaster advanced therapy waveforms offering the ability to easily and quickly provide patients with an array of programming waveforms, frequencies and combinations of options to ensure long term pain relief, all available on the Apple Watch or iPhone controller.

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