Frequently Asked Questions
For Healthcare Professionals
For Patients and Families
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The ApiFix procedure is indicated for patients:
The best way to find out if the ApiFix procedure is a viable alternative for you is to consult a pediatric orthopedic specialist.
Review Indications for Use, Contraindications, Warnings, and Precautions
Yes, the ApiFix system has CE Mark approval and is FDA approved as a humanitarian use device.
The ApiFix procedure utilizes a unilateral approach, which means surgeons expose and work on one side of the spine. In fusion procedures, surgeons are typically working on and implanting devices on both sides of the spine.
In a spinal fusion procedure, scoliosis correction is achieved by permanently fusing 7 to 12 vertebrae of the spinal column. The ApiFix procedure enables curve correction, but does not fuse the spine, which preserves motion compared to fusion surgeries.
The ApiFix procedure uses three anchor points while fusions could use more than 10 anchor points to treat similar size curves.
While both the ApiFix procedure and anterior vertebral body tethering (VBT) enable more motion than spinal fusion, there are differences.
The main difference is that the ApiFix procedure utilizes a posterior approach (from the back), which is a familiar approach for orthopedic surgeons. VBT, on the other hand, uses an anterior approach (from the side), which could require the patient’s lung to be deflated during the procedure. While anterior approaches to the spine are not new, posterior approaches are more commonly utilized by orthopedic surgeons.
Another difference is that the ApiFix procedure uses three anchor points, while VBT can have an anchor point at every vertebral body in the curve.
The ApiFix procedure has been used to treat more than 600 patients and has 10+ years of clinical data. Outcomes from patients treated with the current ApiFix system and under current indications (n=83) include:
Patients typically stay in the hospital for 1-2 days after the procedure.
Patients are usually back in school within 2 weeks after the procedure. When you can return to school or work should be discussed with your physician.
Walking is encouraged following the procedure. Return to certain sports and activities can begin 4-6 weeks after the procedure. Discuss the type of sports and activities with your physician to determine the right timeframe for you.
Yes, you can walk through metal detectors and security scanners after an ApiFix procedure. You may want to inform the personnel operating the equipment that you have a medical implant.
1As of February 2020.
268 of the 83 patients with follow-up x-rays.