9 spine devices granted breakthrough device designation

Alan Condon -   Print  |
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The FDA's Breakthrough Devices Program is designed to accelerate the development, assessment and review of medical devices that provide effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Here are nine spine devices that received the designation this year:

1. Premia Spine's Tops system: a facet joint replacement device for the lumbar spine

2. Theradaptive's Osteo-Adapt SP: a regenerative implant indicated for transforaminal lumbar interbody spinal fusion

3. Amber Implants' VCFix system: a 3D-printed device to treat vertebral fractures

4. Carlsmed's Aprevo: s 3D-printed interbody designed for the treatment of adult spinal deformity

5. Auctus Surgical's VBT system: a vertebral body tethering system that has a nonfusion approach to scoliosis treatment

6. Spino Modulation's Miscoli system: a vertebral body tethering system to treat adolescent idiopathic scoliosis

7. Cerapedics' P-15L: a bone graft for the treatment of degenerative disc disease

8. Spinal Stabilization Technologies' PerQdisc: a lumbar nucleus replacement system

9. Intelligent Implants' SmartFuse: a device used to remotely stimulate, control and monitor bone growth in lumbar spinal fusion patients

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