Pioneer Surgical Technology said that the clinical results of the two-year follow up on the NuBac IDE feasibility study patients was presented at the recent 10th annual meeting of The International Society for the Advancement of Spine Surgery (SAS) in New Orleans by Domagoj Coric, MD and chief of department of neurosurgery at Carolina's Medical Center.
The NuBac implant system is the Nucleus Replacement device that utilises an articulating inner ball and socket design that seeks to achieve load sharing and uniform stress distribution under various physiological loading conditions.
Pioneer Surgical claimed that the NuBac implant is made of Peek-Optima material which offers biocompatibility, biodurability, excellent wear resistance and radiolucency.
Pioneer said that the NuBac became the first nucleus replacement device to gain FDA IDE pivotal study approval. Pioneer started the pivotal study early last year and has 20 study sites with over 40 investigators across the country.
Pioneer continues to market other P3 motion preservation products in Europe including the NuNec artificial cervical disc and the BacJac interspinous decompression device.
Dr Coric said: “The 2-year follow up results on the feasibility study patients are very impressive. From a safety point, 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.”
Chip Bao, CTO of Pioneer, said: “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. We are very fortunate to have so many prominent spine surgeons, both in private practice and major academic institutions, willing to participate in this IDE pivotal study. The results from our European experience give us a lot of excitement as we strive to enter the US market with these products.”