Orthofix gets FDA approval and CE-Mark for bone growth stimulators
Orthofix International has received approvals from the US Food and Drug Administration (FDA) and the CE-Mark in Europe for the next-generation PhysioStim bone growth stimulators.
The new devices have been developed as a non-surgical treatment option for patients who have suffered nonunion fracture to an extremity but do not display any visible signs of healing.
Based on the firm’s PEMF technology platform, the growth stimulators use a pulsed electromagnetic field (PEMF) signal to trigger a low-level electrical field at the site of injury for stimulation of bone healing.
Designed to fit according to patients’ individual bodies, the PhysioStim devices are available with specific features for nonunion fractures to the arm, wrist, hand, clavicle, hip, shoulder, thigh, ankle, lower leg or foot.
Orthofix International chief scientific officer James Ryaby said: “Bone growth stimulation therapy is a safe, effective and proven treatment for patients who have a fracture to an extremity that won’t heal.
“Bone growth stimulation therapy is a safe, effective and proven treatment for patients who have a fracture to an extremity that won’t heal.”
“When patients follow their prescription, their rate of successful healing is improved. The new mobile app is a great tool to foster better adherence to the prescribed treatment because it empowers the patient to take an active part in their recovery.”
Orthofix has also developed an accompanying mobile application called STIM onTrack to facilitate remote monitoring of patient adherence to prescription.
The app also helps patients through their recovery process by providing treatment calendars and educational resources, and sending therapy reminders.
Currently, Orthofix is evaluating Physio-Stim system to treat osteoarthritis of the knee. The company is also assessing RCStim system as an adjunctive treatment for surgical repair of full-thickness rotator cuff tears, and Cervical-Stim system for odontoid fractures in three separate investigational device exemption (IDE) clinical trials.