Bio2 launches study of bioactive glass spinal implant
By Admin | November 27, 2018
Orthopedics company Bio2 Technologies has received FDA approval to begin enrollment in an IDE clinical study to evaluate its Vitrium bioactive glass as a cervical interbody fusion device. Vitrium will be evaluated as a structural device that facilitates bone remodeling via a gradual conversion from Vitrium to the patient’s own bone.
A proprietary process is used to produce Vitrium’s structure and porosity, enabling bone conductivity. Vitrium represents an innovative approach to a well-studied osteostimulative mechanism of action with a long track record of safe clinical use, according to the Woburn, Mass. company.
The randomized, controlled, non-inferiority pivotal study will capture safety and effectiveness data with a 12-month endpoint. Vitrium is currently in commercial use under 510(k) clearances as a bone graft substitute.
The results of the company’s study on sheep, presented at last year’s North American Spine Society, showed that Vitrium has a safe resorption/bone formation profile, stimulation of new bone formation, and strength to share/bear physiologic loads — all ideal characteristics of an interbody fusion device, according to Bio2 Technologies COO Janet Krevolin.
For more information, please read Bio2 launches study of bioactive glass spinal implant by Medical Design & Outsourcing.