Inion introduces its First Biodegradable Spinal Implant in Europe
CE Mark received for S-1TM Anterior Cervical Fixation System
Inion has received a CE Mark for the S-1TM Anterior Cervical Fixation System for spinal applications. CE Mark is required by a number of accredited bodies to medical device manufacturers prior to commercial distribution in the European Union.
S-1TM is a biodegradable anterior cervical fusion plate for graft containment in fusions of the cervical vertebrae, which are the first seven vertebrae and are located at the top of the spinal column. These procedures are carried out in the treatment of chronic back conditions where surgeons fuse two adjacent vertebrae together in order to stabilise the area and alleviate pain. The advantage of biodegradable devices for spinal surgery, which is viewed as relatively high risk, is that they negate the need for further surgery to remove the implant.
Inion produces an extensive range of biodegradable medical devices for a number of clinical applications. S-1TM is the first spinal product that Inion has introduced and adds a fifth area to the Company's biodegradable product range. A programme of clinical post-marketing work is scheduled to begin later during 2005, success of which is anticipated will lead to a full scale launch of the S-1TM product during 2006.
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