NuVasive Recalls Scoliosis Treatment Devices

NuVasive recalls scoliosis treatment devices

NuVasive recalls scoliosis treatment devices
The end cap separation is best seen on an AP X-ray as pictured above.

NuVasive voluntarily issued an Urgent Field Safety Notice (FSN) last month recalling the MAGEC System Model X.

The magnetically controlled growing rod devices, designed to brace the spine during growth and minimize the progression of scoliosis, were recalled after post-implantation separation of the actuator end cap was observed in the Model X’s rods. The FDA labeled this as a class II recall, meaning devices will be pulled from the market for new implantation.

According to the FSN, the actuator end cap separated in approximately 0.5% of the devices implanted. If the end cap becomes separated, the internal components of of the actuator may be exposed to bodily fluids and cause the components to deteriorate at an accelerated rate. The long term effects are currently unknown and the cause of this issue is under investigation.

NuVasive recommends that surgeons perform routine clinical follow-up and discuss potential clinical implications and risks with patients who received affected rods. Due to the low failure rate, the NuVasive does not recommend removing MAGEC X implants from patients that do not exhibit signs of end cap failure. In the event the end cap has not separated, the risk of rod revision actually outweighs the risk of end cap failure. 

For further information, read the Nuvasive’s FSN here.

Via: Scoliosis Research Society

Spinal Implants Market

The thoracolumbar deformity correction market was valued at approximately $490 million in 2018. The thoracolumbar deformity correction market comprises anterior and posterior fixation devices, which span multiple levels and are for treating deformity conditions, such as scoliosis, kyphosis and lordosis. It should be noted that many of the posterior fixation devices used in degenerative thoracolumbar fixation procedures may be modified to treat deformity cases.

Scoliosis is an abnormal condition of the spine where the lateral curvature is not straight but resembles an “S” shape. Typically, conservative treatment is adequate to treat the disease, but surgery is needed in severe cases. Surgery would be considered if the practitioner discovers that the thoracic (mid-back) curve is greater than 50 degrees and increasing in pain, there is a progressive thoracolumbar curve, a low back curve, the heart and lungs are being affected by the curvature or there is apparent deformity. Spine treatment through surgery includes discectomy, the removal of either one or more intervertebral discs, and osteotomy, the remocal of bone. Once either one of those are removed, the surgeon follows up with spinal fusion to stabilize the spine. The surgeon uses spinal instrumentation, such as rods and screws, to keep the spine in its rigid position.

The deformity correction market size remains relatively stable and is based largely on the population that requires treatment for hereditary deformity conditions. As a result of a stable market size, coupled with capped hospital pricing and competitive pricing pressures, the market value is expected to decrease throughout the forecast period.

To read more, please refer to iData Research’s 2019 report Spinal Implants Market Analysis | United States | MedSuite  featuring interviews, procedural volumes, and forecasts up to 2025.

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