03.26.15
Valencia, Calif.-based Bioness Inc.’s Stimrouter neuromodulation system has been implanted in four patients for an ongoing Canadian pilot study to evaluate device use in the treatment of overactive bladder symptoms. The system already has U.S. Food and Drug Administration clearance for chronic, intractable pain of peripheral nerve origin. Now, this minimally invasive technology is being studied as an alternative treatment for the 35 million people in the United States who suffer from overactive bladder symptoms and the 10 million who receive treatment for it, which contributes $66 billion in annual cost to the U.S. healthcare system.
In the pilot study, subjects with documented refractory overactive bladder will receive tibial nerve stimulation via the Stimrouter implantable lead and external pulse transmitter. The subjects will manage their treatment at home in accordance with the defined protocol, with periodic in-clinic outcome visits. The device is equipped with a feature to track usage and compliance during the six month trial.
While the Stimrouter has demonstrated efficacy in relieving peripheral nerve pain, the technology has the potential to be leveraged for even more applications.
“The Stimrouter is a platform technology with a design that we believe has applications outside of its current indication, chronic peripheral pain,” said President and CEO Todd Cushman. “This pilot study demonstrates the first of several investigations with the goal of expanding Stimrouter use in markets of unmet need or existing markets that seek the appropriate neuromodulation solution.”
Bioness makes devices to address mobility, independence and quality of life.
In the pilot study, subjects with documented refractory overactive bladder will receive tibial nerve stimulation via the Stimrouter implantable lead and external pulse transmitter. The subjects will manage their treatment at home in accordance with the defined protocol, with periodic in-clinic outcome visits. The device is equipped with a feature to track usage and compliance during the six month trial.
While the Stimrouter has demonstrated efficacy in relieving peripheral nerve pain, the technology has the potential to be leveraged for even more applications.
“The Stimrouter is a platform technology with a design that we believe has applications outside of its current indication, chronic peripheral pain,” said President and CEO Todd Cushman. “This pilot study demonstrates the first of several investigations with the goal of expanding Stimrouter use in markets of unmet need or existing markets that seek the appropriate neuromodulation solution.”
Bioness makes devices to address mobility, independence and quality of life.