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Thursday, Sep 28, 2023

Valencia Medical Device Maker Secures FDA Approval

Bioness Inc. has received approval from the Food and Drug Administration to sell a nerve-stimulating device for pediatric patients with foot disorders, the company said Tuesday. The Valencia biomedical device company’s L300 Foot Drop System device is designed to treat foot drop, which causes walking difficulty in people with nerve injuries or diseases, including cerebral palsy. Bioness said its device is the first to receive FDA approval for pediatric patients. “Having another potential intervention to offer children and families impacted by foot drop opens up the opportunity for us to not only promote physical development, but improve the independence of these children,” said Dr. Michael Armento, a pediatric physiatrist at Children’s Specialized Hospital in New Jersey, in a statement issued by the company. The device is comprised of three components: a small wireless sensor in the shoe, a brace-like leg cuff worn just below the knee and a hand-held remote control. When a patient takes a step, the device sends a low-level electrical pulse to the leg nerves, which controls the muscles responsible for lifting the foot. The stimulation causes the foot to lift at the right time, leading to increased speed and capability of walking. Bioness had previously received approval to sell the device to adult patients suffering from multiple sclerosis. The systems run in excess of $5,000, depending on customization options.

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