US Food and Drug Administration (FDA) has granted 510(k) clearance to market DePuy Synthes’ Spine Synapse Occipital-Cervical-Thoracic (OCT) System with posterior cervical screws.
The company claims this is the first time cervical screws have been indicated for use with a screw-rod posterior fixation system, while screw placement in the system was previously limited to use for fixation in the thoracic spine (T1-T3) and occiput only.
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Weill Cornell Medical College Hospital for special surgery medical director Todd Albert and professor of orthopaedic surgery Korein-Wilson said in a joint statement: "This is very exciting news as it will allow us in the surgeon community to further drive education and research on these important techniques.
"Additionally it enables us to work with companies like DePuy Synthes to create new, innovative solutions to help improve patient care in the posterior cervical space."
Synapse OCT System, including Synapse, OC Fusion and Axon, is intended to offer immobilisation and stabilisation of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3).
The system is also intended for traumatic spinal fractures and dislocations, instability or deformity, failed previous fusions, tumours involving the cervical / thoracic spine and degenerative disease, including intractable radiculopathy and / or myelopathy, neck and / or arm pain of discogenic origin, and degenerative disease of the facets with instability.
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By GlobalDataSpine franchise unit leader Karen Rowley said: "This expanded indication is significant in that DePuy Synthes Spine is now able to sponsor education on the technique, and contribute to a greater understanding of its use in treating conditions of the cervical spine.
"As a company, we continue to pioneer new techniques, expand our portfolio of comprehensive solutions and provide industry leadership in education, research and innovation."
In addition, the system is intended to restore integrity of the spinal column in the absence of fusion for a limited time period in patients with advanced stage tumours, involving the cervical spine.
By using the 3.5mm / 5.5mm and 4mm / 5.5mm titanium tapered rods, the Synapse OCT System can also be linked to the titanium DePuy Expedium Spine System.
