The FDA granted ApiFix, a motion-preservation scoliosis correction company, the humanitarian device exemption for its minimally invasive deformity correction system.
Four key points:
1. The system is designed for patients with progressive adolescent idiopathic scoliosis deformity, which can affect individuals from age 10 to 21.
2. During its decision-making process, the FDA evaluated data from patients treated with the system since 2012. The study demonstrated safety and clinical benefits for the non-fusion deformity correction.
3. Surgeons can treat patients with Lenke Type 1 and Type 5 curves in progressive AIS patients. The posterior dynamic deformity correction system acts as an "internal brace" for patients.
4. The system has a self-adjusting rod mechanism and motion-preserving polyaxial joints for postoperative corrections.