MILFORD, Conn., May 11 /PRNewswire/ -- A team of clinical investigators presented preliminary data from a pilot study of the TOPS(TM) System at the Spine Arthroplasty Society (SAS) Meeting in New York City on Friday, May 6 and Saturday, May 7. The initial data shows an improvement in pain and function scores for patients who underwent implantation of the TOPS(TM) device after failure of conservative treatment to relieve back and leg pain. Impliant is developing the TOPS(TM) System, a total motion-preserving posterior spine implant designed to stabilize, but not fuse, the affected vertebral level to alleviate pain stemming from degenerative facet arthrosis, spondylolisthesis, and spinal stenosis.
"Patients with degenerative spinal stenosis, spondylolisthesis, and facet arthropathy are often excluded from having a total disc replacement (TDR), as increased segmental motion can exacerbate dorsal spondylolitic changes," said lead investigator, Dr. Luiz Pimenta, Department of Spine Surgery, Santa Rita Hospital, Sao Paulo, Brazil. "Data presented at the SAS conference show that the TOPS(TM) System may offer a novel mechanism for excellent dynamic, multiaxial, 3-column stabilization after complete neural decompression for the population of patients for whom TDR is contraindicated."
Among the group, scores on various scales indicated positive patient outcomes as follows:
* On the Visual Analogue Scale (VAS), the average group score dropped
from 8.2 preop to 3.5 at three months postop; and
* On the Swiss Spinal Score (SSS), the average group score dropped from
71.6 preop to 50 at 3 months postop.
"We are encouraged by these results and are moving forward with plans to expand the clinical investigation of the TOPS(TM) System," said Ron Sacher, CEO of Impliant.
Impliant Inc. is a privately held company focused on developing motion preserving posterior spine solutions. The company is currently developing the TOPS(TM) System, which is designed to alleviate pain resulting from degenerative facet arthrosis, spondylolisthesis, and spinal stenosis by stabilizing but not fusing the affected vertebral level. Impliant does not have FDA approval to market the TOPS(TM) System in the United States. Impliant is headquartered in Milford, CT with research facilities located in Ramat Poleg, Israel. For more information about Impliant, please visit http://www.impliant.com/.
Contacts: Impliant Inc.
Ron Sacher, CEO