RevBio said it has received investigational device exemption (IDE) approval from the FDA to conduct a multi-center randomized controlled pivotal clinical trial to use TETRANITE to reintegrate cranial bone flaps, which are portions of the skull that are temporarily removed by neurosurgeons to perform brain surgery.
This clinical trial is designed to demonstrate that TETRANITE can immediately fixate cranial flaps and enable bone fusion in craniotomy and cranioplasty procedures to improve cosmesis, increase flap stability for patient comfort, and help prevent cerebrospinal fluid leaks, which can cause significant pain and lead to serious infections. All of these complications are known limitations of the current standard of care which consists of plate and screw fixation systems.
This clinical trial will enroll up to 204 patients. Half of these patients will receive TETRANITE and the other half will receive standard cranial plate and screw systems to fixate their cranial bone flaps. Typically, craniotomy procedures are required to remove a brain tumor, treat an aneurysm, relieve intracranial pressure, or perform deep brain stimulation. Cutting into the skull leaves a kerf line, a continuous gap between the bone flap and surrounding skull. The flap is temporarily removed to conduct the brain surgery. In the surgical closure process, the cranial flap is secured back into place with titanium plates and screws. The kerf line, however, is typically not filled or sealed, which compromises the ability of the flap to integrate with the surrounding bone because the width of the kerf is too great a gap for bone cells to cross. As a regenerative bone adhesive placed into the kerf, TETRANITE immediately fixates the bone flap in its desired position, fills the gap, and provides a biological bridge for bone cells to travel from the surrounding skull. This allows bone fusion to occur and the bone flap to solidly heal.
