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Pioneer Surgical Technology, Inc., based in Marquette, announced in June that findings from a clinical study on one of its products were presented at a spinal surgeons' annual conference.

The results were from a two-year follow-up feasibility study on the NuBac device, a spinal implant with an articulating ball-and-socket design. It is a next-generation nucleus replacement device made of a material called PEEK-OPTIMA, for better compatibility and durability.

The study was presented at the 10th annual meeting of The International Society for the Advancement of Spine Surgery, in New Orleans. The presentation was made by Domagoj Coric, M.D., chief of the department of neurosurgery at Carolina's Medical Center, who says the device gave great results.

"The two-year follow up results on the feasibility study patients are very impressive," says Coric. "From a safety (standpoint), there were no implant expulsions in this study; which has been the main challenge for all other nucleus devices. I am pleased with the improvements I have seen in these patients' clinical outcomes as well."

The FDA approved NuBac for this study in early 2009, and Pioneer began the study with 20 study sites across the country, and 40 lead investigators like Coric.

Chip Bao is the company's chief technology officer, and says, "The enthusiasm we have received from the spine surgeons reflects their desire for a less invasive and less bridge-burning motion preservation device. This study will help us understand if we can meet their expectations."

Pioneer, founded in 1992, currently markets other spinal range-of-motion preservation devices in Europe, including NuNec, an artifical cervical disc, and BacJac, an interspinous decompression device.

Writer: Sam Eggleston
Source: Fred J. Taccolini, Pioneer Surgical


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