New MyoCycle Models on Market After MYOLYN Wins FDA Clearance
The second version of the MyoCycle, a functional electrical stimulation (FES) bike designed for people with motor disabilities, including Parkinson’s disease, is now available in the U.S. after winning the needed go-ahead from federal regulators.
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to developer MYOLYN for the FES bike — meaning that this new MyoCycle version can be marketed as a safe and effective medical device for those with Parkinson’s and other disorders and injuries affecting motor function.
The device, dubbed a “cycling therapy system,” combines speed cycling with the application of small electrical charges to help muscles contract and move — a therapy known as FES. It works to boost muscle strength as well as increase physical and mental well-being.
“The new models of the MyoCycle demonstrate MYOLYN’s commitment to innovation and focus on meeting client needs. These new systems provide additional therapeutic benefits to people with more diverse needs and better meet the rigorous demands of the clinical setting while maintaining the ease-of-use that made the initial MyoCycle so successful,” Alan Hamlet, PhD, CEO of MYOLYN, said in a press release.
The cleared stationary FES bike models, designated Home, Home Plus, Pro, and Pro Plus, are now available for sale and shipment.
Parkinson’s is characterized by the gradual loss of specific cells in the brain that produce dopamine, a chemical messenger necessary for movement and coordination. Loss of dopamine is associated with tremor, slowness of movement, stiff muscles, weakness, impaired coordination, and other symptoms, all hallmarks of Parkinson’s.
Exercise is thought to promote the release of biomolecules, which help to protect brain cells from degeneration and slow the progression of Parkinson’s-related symptoms.
Studies have shown that forced exercise programs have therapeutic benefits for people with Parkinson’s. Forced exercise typically involves a program with a trainer and the use of a stationary tandem bike, in which patients are made to move for longer times, and at a higher intensity, than they would be able to do by themselves.
Hamlet and Matthew Bellman, the co-founders of MYOLYN, are both engineers with PhDs in robotics, and have researched the benefits of FES cycling for people with Parkinson’s. Their findings suggest that cycling at a constant, controlled cadence — the rate at which a cyclist pedals — together with FES muscle activation, has the same advantages as forced exercise. It also offers all the usual benefits of FES, which include relaxation of muscle spasms, prevention or delay of muscle loss, re-education of muscles, and increased blood circulation.
The new MyoCycle models have extra stimulation channel options for users. Specifically, there are up to 10 channels of stimulation, new walking and cycling modes, more muscle group targeting options for core and lower leg muscles, and new FDA-cleared benefit of muscle re-education and real-time performance feedback, as well as other adjustable stimulation parameters.
According to the neuro-rehabilitation technology company, the new MyoCycle — with the targeting of the core and lower legs, thighs, and glutes — can benefit people with several medical conditions that have led to lower-body paralysis or muscle weakness. These conditions include spinal cord injuries, stroke, multiple sclerosis, cerebral palsy, general orthopedic rehabilitation, as well as Parkinson’s disease.
“The new MyoCycle models represent five years of post-market experience with the original MyoCycle models,” Bellman said. “The first MyoCycle has and will continue to help many individuals, and in listening to client feedback and looking for ways to innovate, we are excited to launch this new MyoCycle that furthers our mission to empower people to move.”