The FDA has granted breakthrough device designation for Spino Modulation's MIScoli system, a vertebral body tethering system to treat adolescent idiopathic scoliosis.
Four notes:
1. Vertebral body tethering is a less invasive alternative to spinal fusion, the standard of care when adolescents require surgical intervention to correct curvature of the spine. Patients are seeking treatments that are less traumatic than fusion, which is associated with longer recovery times, growth and mobility restrictions, longer term pain and narcotics requirements and significant surgical scars, according to a June 22 news release.
2. The technology places screws in a flexible tether or rope, which allows the patient to be flexible and continue to have motion throughout the spine. The procedure is designed to maintain flexibility and lead to fewer problems than patients have post-spinal fusion.
3. Toronto-based Spino Modulation, founded by three spine surgeons, is a subsidiary of Spinologics, which is conducting an ongoing clinical trial to research MIScoli as a treatment option for adolescent idiopathic scoliosis to reduce deformity and prevent its worsening in children who are at high risk for curve progression while also preserving motion.
4. The FDA designation expedites the time taken to develop and review products in clinical trials. It is intended to help patients get more timely access to devices that could provide more effective treatment for life-threatening or irreversibly debilitating conditions.