Bioness begins pilot study of StimRouter neuromodulation device to treat overactive bladder

US-based Bioness has started a Canadian pilot study of the StimRouter Neuromodulation System for the treatment of overactive bladder (OAB).

Free Report

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.

By GlobalData

By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Four patients have currently successfully been implanted with the StimRouter Neuromodulation System to evaluate the device in the treatment of overactive bladder symptoms.

StimRouter, a minimally invasive neuromodulation medical device, secured FDA clearance as a treatment for chronic, intractable pain of peripheral nerve origin.

This minimally invasive technology is being examined as an alternative treatment for the 35 million people in the US who suffer from overactive bladder symptoms and the 10 million who receive treatment for it, which contributes $66bn in annual cost to the US healthcare system.

During the pilot study, patients with documented refractory overactive bladder will receive tibial nerve stimulation via the StimRouter implantable lead and external pulse transmitter.

“Four patients have currently successfully been implanted with the StimRouter Neuromodulation System to evaluate the device in the treatment of overactive bladder symptoms.”

The company said patients will manage their treatment at home in accordance with the defined protocol, with periodic in-clinic outcome visits.

The neuromodulation device is equipped with a feature to make a track of the usage and compliance during the six-month trial.

StimRouter showed efficacy in relieving peripheral nerve pain and this technology has the potential to be used for more applications.

Bioness president Todd Cushman said: “The StimRouter is a platform technology with a design that we believe has applications outside of its current indication, chronic peripheral pain.

“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.”

StimRouter consists of an implanted lead, external pulse transmitter (EPT) and conductive electrode, controlled by a small handheld wireless control unit.