US, EU Regulatory Approvals for New Orthofix Bone Growth Stimulators

By Julie A. Vetalice

Orthofix (OFIX) announced FDA premarket approval and European CE Mark approval for next-generation CervicalStim™ and SpinalStim™ bone growth stimulators. U.S. availability will include the Stim onTrack™ mobile app to support patient engagement and real-time delivery of data to the physician.

The Class III devices employ low-level pulsed electromagnetic field (PEMF), designed to activate and augment the body's natural healing process, providing a noninvasive treatment to promote post-op spinal fusion.

Recently, NASS issued first-of-its-kind coverage recommendations for electrical bone growth stimulators, supporting use of PEMF stimulation devices as an adjunct to spinal fusion.

OFIX is conducting IDE clinical trials to collect safety and effectiveness data for the CervicalStim system in treating odontoid fractures and Physio-Stim for knee OA.

Sources: Orthofix International N.V.; ORTHOWORLD Inc.

Tags: CE Mark, Premarket Approval, Regulatory