Bio2 Technologies has recruited the first patient in the randomised, multi-centre and clinical trial of the Vitrium cervical interbody device.
The company has secured an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to carry out the study after pre-clinical studies showed Vitrium implants are substituted with a newly regenerated bone while exhibiting sufficient strength for use in load-bearing reconstructive surgeries such as spinal fusion.
Vitrium cervical interbody clinical trial
Vitrium is a new class of resorbable orthobiomaterial with broad application in musculoskeletal surgery.
The Orthopaedic Institute of Western Kentucky’s Dr Brandon Strenge conducted the procedure on the index patient.
Dr Strenge said: “I am very excited to be a part of this study evaluating a device that harnesses the patient’s own regenerative process to achieve a fusion without metal or plastic left behind.”
The company will enroll up to 168 patients in a prospective study to compare the Vitrium cervical implant to allograft (cadaver bone).
Vitrium will enable the surgeon to reconstruct bony anatomy without the clinical compromises inherent in current technologies.
Vitrium, constructed exclusively of bioactive glass, is porous, load-bearing, osteoconductive and bioactive.
Vitrium resorbable implants serve as an alternative to the machined allograft, porous metal, and PEEK. According to the company, Vitrium interbody devices are fully replaced by bone resulting in Total Biologic Fusion (TBF).
Bio2 Technologies chief operating officer Dr Janet Krevolin said: “We’re excited to have the first patient implanted with the Vitrium Cervical Interbody Device.
“We look forward to returning to the gold standard outcome of a total biologic fusion with no foreign material remaining in the disc space.”
Based in Woburn of Massachusetts, Bio2 Technologies is involved in the development of advanced orthobiomaterials through using an advanced process. It also commercialises implantable devices constructed from these materials for distribution through exclusive marketing partners. – NS Medical Devices