Mainstay Medical has begun enrolling patients in a clinical trial of its implanted ReActiv8 device after receiving approval from Australian Ethics Committees, the devicemaker said Monday.
The company plans to enroll up to 96 patients, spokeswoman Eilish Joyce told Device Daily Bulletin.
The trial is currently enrolling patients ages 18 to 65 with a first occurrence of low back pain and last relatively pain-free experience more than 90 days before enrollment, and for whom surgery is not indicated, at sites in New South Wales, Victoria and Queensland, Australia.
Mainstay CEO Peter Crosby says input the company received from specialists around the world led them to create a new approach to treating chronic low back pain. ReActiv8, Mainstay says, is a small, implanted device that is used in 30-minute sessions twice a day and stimulates the nerves, helping to contract and relax the muscles that stabilize the lower spine and prevent it from moving into painful positions.
Results from an earlier European feasibility study showed a statistically significant improvement in key outcome measures such as reduction in pain and disability from chronic low back pain and improved quality of life, according to the company.
ReActiv8-A will evaluate as its primary outcome measure pain ratings on the 11 Point Numerical Rating Scale within 90 days and is expected to be completed by January 2017. Mainstay is looking to obtain CE Marking by the fourth quarter of next year. — Lena Freund
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