Revolutionizing Scoliosis Treatment: Globus Medical & ZimVie Receive FDA Approval

REFLECT™ & Tether™ REFLECT™ & Tether™ (Via Globus Medical and ZimVie)

Globus Medical and ZimVie have both recently received FDA approval for groundbreaking new devices set to correct progressive scoliosis in young patients. Globus Medical’s REFLECT™ Scoliosis Correction System and Zimvie’s Tether™ Vertebral Body Tethering System are indicated for skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis.

Scoliosis refers to an abnormal sideways curvature of the spine, often presenting mild cases that do not require medical treatment. However, progressive scoliosis involves a curvature that worsens over time, leading to consistent back pain, inflammation in the back bones, breathing difficulties due to pressure on the rib cage, and potential injury to the heart and lungs. These symptoms, among others, significantly impact the quality of life as patients age.

Diagnosis and the Cobb Method

In scoliosis diagnosis, the severity is often assessed using the Cobb angle measurement. This method involves measuring the angle between the upper border of the upper vertebra and the lower borders of the lowest vertebra to determine the curvature of the spine. Here’s how the different degrees of curvature are classified:

  • Curves ranging from 1 to 9 degrees are typically not considered indicative of scoliosis.
  • A curve between 10 and 24 degrees is categorized as mild scoliosis, requiring careful monitoring, particularly in adolescents.
  • When the curve measures between 25 and 39 degrees, it is classified as moderate scoliosis. At this stage, bracing and treatment are recommended to prevent further spinal deformity, especially if the curvature is present before skeletal maturity.
  • If the Cobb angle exceeds 40 degrees and continues to progress, surgery may be recommended based on the impact of the condition on the patient’s quality of life.

The REFLECT™ Scoliosis Correction System

The REFLECT™ Scoliosis Correction System developed by Globus aims to address patients with a significant cobb angle of 30 to 65 degrees. Through a minimally invasive procedure, this innovative system utilizes a flexible cord to control the spinal curve while still allowing for growth, which is crucial for adolescents. The non-fusion nature of this device is a key feature, as it enables the patient to harness their body’s natural corrective abilities without impeding potential growth or experiencing the negative side effects associated with spinal fusion surgery. By preserving motion, maintaining stability, and supporting natural growth, this development brings tremendous excitement for young patients and their parents, offering a minimally invasive option to treat progressive scoliosis and preserve their current and future quality of life.

The ZimVie Tether™ Vertebral Body Tethering System

Globus Medical’s REFLECT™ Scoliosis Correction System will enter direct competition with ZimVie’s Tether™ Vertebral Body Tethering System, a similar device designed for correcting adolescent scoliosis. ZimVie holds the distinction of being the first FDA-approved vertebral body tethering system, while Globus Medical’s REFLECT™ system introduces innovative advancements. The ZimVie Tether™ presents an additional, minimally invasive option for treating adolescent scoliosis, offering the advantages of fusion within a minimally invasive procedure while simultaneously preserving the patient’s lifestyle, mobility, and leveraging their growth to aid in scoliosis treatment.

ZimVie, Globus Medical and The Spine Market

These remarkable products from these two exceptional companies are poised to revolutionize the spinal device market. Not only do they offer top-notch quality as a device, but they also bring life-changing benefits to children in need of scoliosis correction treatment. With their innovative designs, ZimVie and Globus Medical have set a new gold standard for scoliosis treatment, shaping the market and profoundly improving the lives of children affected by this condition. Prepare for a transformative shift in the field of scoliosis treatment as these devices pave the way for a brighter future. For more insights and updates on the ever-expanding and innovative spinal device market, please check out our latest Global, US or European Spinal Device Market report below!

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References:

  1. ReflectTM Scoliosis Correction System. Globus Medical. (2023, May 19). https://www.globusmedical.com/products/REFLECT/
  2. Department of Health & Human Services. (2006, September 1). Scoliosis. Better Health Channel. https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/scoliosis#symptoms
  3. Baaj, M. A. (2018, May 25). Cobb Angle Measurement and treatment guidelines. Spine. https://www.spine-health.com/conditions/scoliosis/cobb-angle-measurement-and-treatment-guidelines
  4. Globe NewsWire. (2023, May 15). Globus Medical Announces FDA Approval for its Non-Fusion Scoliosis Correction System, the Latest Advancement for Young Patients with Idiopathic Scoliosis. Globe NewsWire. Retrieved May 19, 2023, from https://www.globenewswire.com/news-release/2023/05/15/2669363/0/en/Globus-Medical-Announces-FDA-Approval-for-its-Non-Fusion-Scoliosis-Correction-System-the-Latest-Advancement-for-Young-Patients-with-Idiopathic-Scoliosis.html.
  5. The tetherTM vertebral body tethering system: Zimvie USA. The TetherTM Vertebral Body Tethering System | ZimVie USA. (n.d.). https://www.zimvie.com/tether
  6. Globus secures FDA approval for reflect scoliosis correction system. NS Medical Devices. (2023, May 16). https://www.nsmedicaldevices.com/news/globus-medical-reflect-scoliosis-correction-system/
  7. Hammerand, J. (2023, May 17). The zimvie tether helps kids with scoliosis – if they can get it in time. Medical Design and Outsourcing. https://www.medicaldesignandoutsourcing.com/zimvie-tether-adolescent-idiopathic-scoliosis-treatment/

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