System-IV is an implant system, which relies on the pedicular fixation. The pedicular fixation (introduced by Prof. Raymond Roy-Camille in the 1960ties) belongs nowadays to the standard procedures in the spine surgery. In the System-IV instruments for the clinical application, no instruments for the preparation of the pedicle are foreseen. Surgeons, who will implant System-IV dispose on their own preferred instruments to open a pedicle and to prepare the seat of a screw.
System-IV is basically suitable for the entire lumbar spine, i.e. from L1 to S1 (sacrum). For patients with small vertebral bodies it shall priorly be verified whether the upper vertebrae (e.g. L2, L1) allow the accommodation of the existing pedicle screws and connection rods.
The SpineShape System IV consists of PCU (polycarbonateurethane) rods having a dedicated cross section with plane parallel sides. Patents are fi led for this cross section allowing for a safe and at the same time smooth anchorage of the rod in the unique pedicle screws made of titanium alloy. This anchorage is assured by nuts of titanium alloy and intermediate pieces of PEEK (polyetheretherketon). The rods exist in three different stiffness (elastic, medium and stiff). The medium and stiff rod is also available as straight and pre-bent. From the medium and stiff rod a stepped version (VaristabTM) is further available, allowing in the cases where a fusion is expected, the connection of an adjacent segment with reduced stiffness. A great advantage of the VaristabTM includes the use of the same pedicle screws and nuts for the stepped end, where only a higher intermediate piece is required. The implants (rods, pedicle screws, nuts and intermediate pieces) are supplied in sterile condition after -ray sterilisation.
About Pedicle Screw/Rod–Based Dynamic Stabilization Devices
Dynamic stabilization is a surgical technique designed to allow for some movement of the spine, while maintaining enough stability to prevent too much movement. Pedicle-based dynamic devices were first designed to stabilize the abnormal segment and to unload degenerated discs and facet joints, while maintaining the same level of normal motion.By unloading the pressure on the degenerated disc and facets, pedicle-based dynamic devices have the potential to reduce pain associated with these anatomical structures. Furthermore, these devices can be used to prevent adjacent-segment disease, either by replacing the whole construct with dynamic rods or by “topping off” the rigid instrumented segment with pedicle-based dynamic devices, avoiding an abrupt change from a rigid construct to the more mobile adjacent segment. It has also been argued that using pedicle-based dynamic devices can promote better fusion because of micromovements across endplates, and can protect from implant failure because of better load sharing through the implant. Finally, these devices can be used to stabilize posterior iatrogenic destabilizing surgery, such as wide laminectomy and facetectomy.
About SpineSave
The company SpineSave has dedicated itself to motion preservation implant systems and offers to the surgeon solutions, which on one hand are based on proven methods and on the other hand are featured with stepwise innovations.https://spinesave.com/