ApiFix receives FDA humanitarian device exemption for MIS scoliosis correction system

Written by Laura Dyrda | August 27, 2019 | Print  |

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.

More articles on spine devices:
FDA grants Fast Track designation for DiscGenics' cell therapy for disc generation
16 spine devices receive FDA 510(k) clearance for neurostimulation
Medtronic spine revenue up nearly 1% to $658M

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