Bio2 Gains Approval to Study Vitrium in Interbody Fusion

By Julie A. Vetalice

Bio2 Technologies received FDA approval to commence enrollment in an Investigational Device Exemption clinical study of Vitrium bioactive glass as a structural cervical interbody fusion device.

Vitrium is presently FDA 510(k) cleared for marketing as a bone graft substitute. This one-year randomized, controlled, non-inferiority pivotal study will evaluate the biomaterial as a device that gradually converts to a patient's own bone, offering an alternative to PEEK and titanium to achieve fusion.

Source: Bio2 Technologies, Inc.

Product Labels: Spinal Fusion

Tags: Regulatory, Trial/Study