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Ranier Technology gets green light to start CAdisc European clinical trial
May 12, 2009
Cambridge, UK based Ranier Technology today confirmed that it has received clearance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to commence the clinical trial of its CAdiscTM- L replacement lumbar spine disc implant.
The trial is planned to take place in five European spinal surgical centres and is anticipated to lead to CE marking, and subsequent sales of the CAdiscTM-L product in European markets during 2010.
CAdiscTM- L is designed to treat Degenerative Disc Disease, a debilitating condition causing severe back pain which seriously impairs the lives of millions. Over a million surgical procedures are undertaken globally each year to treat the condition, usually on patients aged 25 - 50. Conventional surgery removes the diseased disc and fuses the two adjacent vertebrae, precluding further motion at the operative level. In contrast, Ranier's CAdiscTM- L is designed to restore the full natural motion of the spine, and to reduce patients' pain, allowing them to regain their active lifestyles. The global market for lumbar spinal disc implants is set to grow to $1.1 bn by 2017.
CAdiscTM- L is the world's first all polymer, compliant lumbar total replacement disc implant and is designed both to mimic the dynamic mechanical and motion characteristics under loading of the natural disc, and to transmit loads physiologically to adjacent vertebrae. When two lumbar spinal vertebrae are fused together, discs at adjacent levels in the spine are themselves likely to degenerate more rapidly. By sharing loads more naturally and restoring natural motion, it is anticipated that CAdiscTM- L will also protect discs at adjacent levels, and to avoid or delay subsequent surgery.
Dr Geoffrey Andrews, CEO of Ranier Technology commented:
"I am delighted that the MHRA has recognised the validity and value of the body of scientific work underpinning our CAdisc TM-L design. I look forward to CAdiscTM-L transforming the lives of patients currently debilitated by severe back pain."
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