FDA and CE mark approvals granted to Orthofix’s PhysioStim Bone Growth Stimulators

Orthofix International declared the U.S. Food and Drug Administration (FDA) and European CE Mark approvals for its next-generation PhysioStim bone growth stimulators.

The PhysiStim devices enable non-surgical treatment option for patients who have a nonunion fracture to an extremity that has shown no visible signs of healing. These Class III medical devices use a pulsed electromagnetic field (PEMF) signal to induce a low-level electrical field at the fracture site which stimulates bone healing.

Brad Niemann, President of the Orthofix BioStim strategic business unit said “These devices are built on our proprietary PEMF technology platform. Together with our spinal fusion stimulators, they are currently the No. 1 prescribed bone growth stimulators in the U.S.”

The PhysioStim devices will be accompanied by a new application for mobile devices, STIM onTrack. Designed for use with smartphones and other mobile devices, STIM onTrack is free and available in the U.S. through the iTunes App Store. The STIM onTrack mobile app includes a first-to-market feature that enables physicians to remotely view patient adherence to their prescription. Additionally, the app engages patients in their recovery process through treatment calendars, therapy reminders and educational resources. The PhysioStim devices come in different models and are designed to anatomically fit the patient’s body. Specific applications are for treatment of nonunion fractures to the arm, hand, wrist, clavicle, shoulder, hip, thigh, lower leg, ankle or foot. The devices can be worn over clothing, casts or internal and external surgical fixation devices.