Answers to common ApiFix^® procedure questions

Who is eligible for the ApiFix procedure?

The ApiFix procedure is indicated for patients:

• Having Adolescent Idiopathic Scoliosis (AIS) classified as Lenke type 1 or Lenke type 5 having Cobb angle up to 60 degrees
• Early onset scoliosis (EOS), above the age of 6 years old, having Cobb angle up to 75 degrees
• Spinal deformity is flexible
• Appropriate candidate for posterior surgical approach

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 CE Mark and FDA approvals?

Yes, the ApiFix system has CE Mark approval and is FDA approved as a humanitarian use device.

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 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.

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. 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.

Is there clinical evidence to support the ApiFix procedure?

The ApiFix procedure has been used to treat more than 900 patients and has 10+ years of clinical data. Outcomes from patients treated with the current ApiFix system and under current indications (n=83) include:

• 84% of patients had Cobb angle measured ≤30 degrees at last follow-up^1,2
• 68% of patients had Cobb angle measured ≤25 degrees at last follow-up^1,2
• 8.4% of patients had revisions: 1 patient converted to spinal fusion¹

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.