This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Probable Benefit (SSPB) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Minimally Invasive Deformity Correction (MID-C) System
HDE Applicant: ApiFix, Ltd.
Address: 17 Tehelet Street, Misgav Business Park, 20174, Israel
Approval Date: August 23, 2019
Approval Letter: Approval Order
What is it? The Minimally Invasive Deformity Correction (MID-C) System is a non-fusion spinal device intended to prevent spinal curve progression in adolescent patients with idiopathic scoliosis. The MID-C System includes a ratcheting rod made from titanium alloy components that is attached to the spine using screws.
How does it work? The MID-C System is attached to the patient's posterior spine on the concave side of the spinal curvature. Following surgery, the ratcheting rod expands in small increments during activities such as physical therapy.
When is it used? The MID-C System is indicated for use in patients with adolescent idiopathic scoliosis (AIS) for treatment of single curves classified as Lenke 1 (thoracic major curve) or Lenke 5 (thoracolumbar/lumbar major curve), having a Cobb angle of 45 to 60 degrees which reduces to less than or equal to 30 degrees on lateral side-bending radiographs, and thoracic kyphosis less than 55 degrees as measured from T5 to T12.
What will it accomplish? The clinical data suggests that the MID-C System provides probable benefit related to prevention of the spinal curve progression and avoidance of spinal fusion, which is the current standard-of-care treatment. While the rate of reoperations reported for patients was somewhat higher than for spinal fusion, the MID-C System's safety profile is favorable. Patient preference information about the MID-C System was also generally positive.
When should it not be used? The MID-C System should not be implanted in patients who have:
- Any type of non-idiopathic scoliosis
- Thoracic kyphosis in excess of 55 degrees measured between T5 to T12
- Any main thoracic deformity that includes vertebral levels including cranial to T2
- Known history of cancer, or any systemic infection, local infection, or if the skin around the surgery area is damaged
- Spinal cord abnormalities that require treatment
- Presence of a neurological deficit (defined as a motor grade of less than 5 out of 5)
- Bone that is soft or measured to have a T-score (bone density measurement) -1.5 or less
Additional information (including warnings, precautions, and adverse events):
- Summary of Safety and Probable Benefit (SSPB)
- Patient Labeling
- Physician Labeling
- HDE Database Entry