Spino Modulation, a subsidiary of Spinologics, has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for its MIScoli system, a vertebral body tethering (VBT) device used to treat scoliosis in young adolescents.
The MIScoli system is one of a few VBT devices that are under investigation, or limited market release, in many countries, according to Spino Modulation. Various medical device developers have committed to developing VBT solutions to serve an unmet need in the scoliosis surgical treatment market.
The company states that VBT is a promising and less invasive alternative to spine fusion, which is the current standard of care when adolescents need a surgical intervention to correct a curvature of the spine. Spino Modulation add that patients, and their parents, are looking for treatment options that are less traumatic than fusion, which is associated with long in hospital and at-home recovery times, growth and mobility restrictions, longer term pain and narcotics requirements and significant surgical scars.
The FDA breakthrough device program is intended to help patients receive more timely access to certain medical devices that have the potential to provide effective treatment for life-threatening or irreversibly debilitating diseases or conditions, including a prioritised review of market approval regulatory submissions.