NuBac: Will This Implant Overcome the Challenges of Nucleus Replacement Procedures?

posted in Total Disc Arthroplasty, Degenerative Disc Disease, What's New

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Pioneer Surgical Technology, Inc. announced that the U.S. Food and Drug Administration (FDA) granted approval to proceed to IDE Pivotal Study of the NuBac(R) Nucleus Replacement Device for the spine.

Pioneer’s CEO and Chairman of the Board, Matthew N. Songer, MD, MBA says, “This is a huge milestone and accomplishment for Pioneer to be the first to receive FDA approval to start the IDE pivotal study for nucleus replacement.”

The NuBac implant system is the only Nucleus Replacement device that utilizes an articulating inner ball and socket design that seeks to achieve load sharing and uniform stress distribution under various physiological loading conditions while minimizing extrusion risk. The NuBac implant is made of PEEK-OPTIMA(R) material which offers well established biocompatibility, biodurability, excellent wear resistance, and radiolucency.

Spinal Disc Arthroplasty surgery includes Total Disc Replacement (TDR) and Nucleus Replacement procedures. Both techniques seek to relieve discogenic back pain caused by degenerative disc disease, restore stability and flexibility to the affected spine segment. Nucleus Replacement procedures are commonly less invasive, more tissue preserving, and less bridge-burning than TDR surgery. Reducing the risk of having to perform revision surgery in the future would benefit a much broader population than TDR including patients, surgeons, hospitals, and payers.

For more information:
Pioneer Surgical Technology, Inc.
http://www.pioneersurgical.com