Signus receives CE mark for ALIF and cervical cages
Signus has gained CE mark approval for the BIG ST (left) and JASPIS ST implants […]
Signus has gained CE mark approval for the BIG ST (left) and JASPIS ST implants
Signus has announced that it has received CE mark approval for two implants in its product portfolio, the BIG ST anterior lumbar interbody fusion (ALIF) cage and the JASPIS ST cervical cage.
BIG ST is a 3D printed lumbar cage, which can be inserted from an anterior approach, using a minimally invasive retro/transperitoneal approach or using a 45 degree oblique or 90 degree lateral technique. Implanted from an anterior approach it is possible to insert four divergent fixation screws and use it as a standalone fusion device which comes along with both economic benefits and less invasive surgery for the patient, Signus said in a press release.
The implant features a flattened front edge and smooth lateral surfaces combined with a self-distracting design to ensure a reduced preparation and protection of the nerval structures during insertion. An open macroporous structure resembles natural cancellous architecture and enables both growing on and growing in of bone that can be supported by filling the implant with KAINOS Inject.
An increased roughness in conjunction with the Signus toothed cage design secures the anchoring in the bone owing to a high primary stability and reduces the risk of implant migration. The large contact area with the vertebral body reduces the risk of subsidence.
Also to gain recent CE mark approval, the JASPIS ST originates from the RABEA design, which received the world’s first CE-approval for a plane-parallel fusion cage in 1996.
The implant’s titanium grid structure imitates the architecture of natural cancellous bone to optimise inter-corporeal fusion, Signus said in its release. The open design of the implant permits the cage to be packed with natural or synthetic bone graft substitute such as KAINOS Inject, creating the optimal foundation for osseointegration. The roughness of the implant in addition with Signus’ toothed endplate design secures anchorage in the bone owing to high primary stability.
The large surface area of JASPIS ST maximises the area of contact to the vertebral body and reduces the risk of subsidence. Restoration of the intervertebral space can be guaranteed by a large selection of implants that at the same time offer a high degree of intraoperative flexibility, the Signus release stated. In addition to a 0 degree cage JASPIS ST is also available in an 8 degree lordosis angle to restore sagittal balance. All implants are in individual sterile packaging for immediate use.
Original Article: (https://spinalnewsinternational.com/signus-receives-ce-mark-for-alif-and-cervical-cages/)