Answers to common ApiFix^® procedure questions

Who is eligible for the ApiFix procedure?

The ApiFix procedure is indicated for patients with adolescent idiopathic scoliosis (AIS) having single curves classified as Lenke 1 or Lenke 5 measuring 35-60 degrees, which reduce to ≤ 30 degrees on lateral side-bending x-rays.

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

Does the ApiFix system have FDA approval?

Yes, the FDA approved the ApiFix system as a humanitarian use device in August 2019.

How is the ApiFix procedure different than fusion?

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 7 to 12 vertebrae, 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.

How is the ApiFix procedure different than anterior vertebral body tethering?

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, while VBT uses an anterior approach (from the side). 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.

How long do patients stay in the hospital?

Patients typically stay in the hospital for 1-2 days after the procedure.

When can I return to school or work?

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.

When can I return to activities or sports?

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.

Can I go through metal detectors or security scanners with the ApiFix system?

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.

Support for Insurance Denials

Even though a device is approved by the FDA, its use may be limited as health insurers decline to pay for breakthrough technology. Orthopediatrics is committed to increasing patient access and commercialization for the ApiFix procedure through our partnership with PRIA Healthcare and the ApiFix Patient Access Program. The program is designed to accelerate a patient’s access to the ApiFix procedure. Prior authorization and appeals submissions are consistent to each payer with a focus on medical necessity, the patient’s clinical evidence and supporting documentation for ApiFix. If you are a patient or parent seeking support with insurance denials for ApiFix please contact PRIA for more information on this no cost service offered to you:

EMAIL:  apifix@priahealthcare.com

PHONE: (860) 724-2863 FAX: (860) 782-2092