Ranier Technology Limited Receives CE Mark Approval for Cadisc-L Lumbar Spinal Disc Replacement
9/13/2010 7:08:41 AM
CAMBRIDGE, England--(BUSINESS WIRE)--Ranier Technology, the medical device development company focusing on the commercialisation of spinal implants, has announced that it has received CE Mark approval for its Cadisc™-L; an elasto-mimetic spinal disc replacement device for the lumbar spine. The CE Mark approval was received following a review of the company's multi-centre European clinical study and its extensive portfolio of biocompatibility and biomechanical testing.
Dr Geoffrey Andrews, CEO of Ranier Technology commented: “The achievement of the CE Mark for our Cadisc™-L lumbar disc product is a very significant milestone in the history of Ranier Technology. It will allow us to implement our plans for full commercialisation of the Cadisc™-L technology in European healthcare markets, bringing relief and a transformed quality of life to thousands currently suffering from debilitating back pain. Having met both prospective patients, and recipients of Cadisc™-L, I know that there is a great unmet clinical need that Cadisc™-L can be highly successful in addressing.”
Ian Quirk, Director of Clinical and Regulatory Affairs at Ranier, added: “The initial outcomes in the clinical study are very pleasing. By using the Cadisc™-L spinal disc replacement, we found patients had significant reductions in average leg and back pain, and overall disability, and coupled with an increase in quality of life there are very strong indications of early phase performance.”
Cadisc™- L is intended to treat Degenerative Disc Disease of the lumbar spine, a debilitating condition causing severe back & leg pain which seriously impairs the lives of millions. Currently over half a million patients every year undergo conventional surgery which removes the diseased disc and fuses the two adjacent vertebrae together, restricting further motion. More recently, engineers have developed articulating metal disc implants which allow motion to a limited degree, but which place additional loads on adjacent tissues.
In a significant development, scientists at Ranier have utilised the elastomeric and load bearing properties of the company’s Precision Polyurethane Manufacturing technology to develop a polymeric replacement disc which more closely mimiced the bio-mechanical performance of the natural disc. Ranier’s Cadisc™- L is designed to restore the natural, elastomeric motion to the spine, to share the high loads encountered in the lumbar spine with adjacent tissues and to reduce patients’ pain, allowing them to regain their former active lifestyles and enjoy a normal quality of life.
Ranier Technology, located in Cambridge, UK, is a medical device developer utilising its proprietary Precision Polyurethane Manufacturing (PPM) technology to bring next generation, motion preservation spinal implants to clinical use. The PPM technology enables the design and production of load sharing, polyurethane implants with regions of graduated hardness which confer both programmable mechanical properties and high durability under load.
How many patients are treated per year?
About 1 million people are surgically treated every year globally for lumbar disc defects, with over 500,000 patients receiving a spinal fusion procedure in which the diseased disc is removed and replaced with a rigid fixture which eliminates motion at the operative level. Millions more back pain sufferers are either on pain medication or waiting to be treated.
Is this the only product Ranier is developing?
Ranier’s lead products are a compliant lumbar total disc implant, Cadisc™-L and Cadisc™-C, the company’s total replacement disc for the cervical spine. Whilst Ranier’s current focus is on the total disc implants, the PPM technology platform is suited to a wide range of orthopaedic applications. Ranier also produces a range of surgical instruments in support of its Cadisc™-L and Cadisc™-C products.
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