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Raymedica received FDA approval to initiate patent enrollment in the HydraFlex™ Nucleus Arthroplasty System™ Clinical Trial |
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| Food and Drug Administration (FDA) approval has been granted to perform a clinical evaluation of the HydraFlex Nucleus Arthroplasty System for the treatment of DDD. The HydraFlex device replaces the nucleus, or center of the spinal disc,
in your lower back that is not functioning normally. The device is intended
to reduce your pain, improve function, and maintain disc height while
preserving motion at the level where you will have surgery. The treatment
is a potential solution to patients that have not gotten relief from
non-surgical options (conservative care). The HydraFlex Nucleus Arthroplasty
System includes the surgical procedure, implant, surgical instruments,
and your post-operative For more information on spine surgeons participating in the FDA approved clinical evaluation on the HydraFlex™ Nucleus Arthroplasty System™ Technology, please refer to the following investigator websites: US CLINICAL TRIAL TRAINED SURGEONS Kenneth A. Pettine, M.D., Loveland, CO, USA John S. Thalgott, M.D., Las Vegas, NV, USA
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