SpineVision(R) Launches Two of Its Latest Innovations: FlexPLUS(TM) Motion-Preservation Device and 2.5mm-Diameter Version of PediGuard(TM), for Safe Pedicle Screw Placement in Most Challenging Pedicles, Launched at Europe's Largest Spine Meeting, EuroSpine 2007

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SpineVision(R) announced today that it has launched in full release* its innovative motion-preservation system FlexPLUS(TM) and a 2.5mm-diameter PediGuard(TM).

Perhaps the biggest advantages of the FlexPLUS(TM) device are its versatility and ease of use

    With FlexPLUS(TM), SpineVision(R) offers selective options in a single, posterior lumbar pedicle screw system--from fusion to dynamic stabilization--adaptable to the different stages of the disc degeneration cascade. The clear advantage of FlexPLUS(TM) is that it offers various degrees of stabilization: rigid, hybrid and dynamic, providing spine surgeons with more options in the treatment of lumbar disc diseases and allowing Selective Segmental Stabilization (3S) during the procedure.

"As the disc degenerative process is mainly genetically driven there is a place for spine restabilisation in the aging spine," said Pr Le Huec, orthopaedic surgeon at Bordeaux University Hospital, France. "The main indications are dedicated to restabilisation after decompression in dynamic or static lumbar stenosis to prevent kyphotic imbalance. Restoration of sagittal balance and prevention of undue stress on adjacent levels are the best way to avoid adjacent segment disease in transitional zone."

"Giving surgeons the possibility to choose multiple grades of flexibility, the system brings us into a new area in lumbar spine surgery, allowing dynamic restoration according to each spine's expected work and load.," said Dr. Antonio Marques Baptista, a neurosurgeon at Gaia Hospital Porto. "Perhaps the biggest advantages of the FlexPLUS(TM) device are its versatility and ease of use," added Dr. Ely Ashkenazy, a neurosurgeon at Israel Spine Center, Tel Aviv. "For example, FlexPLUS(TM) may be used as a platform for dynamic fixation in patients who need to have their disc movement restrained but who do not need a fusion. And, FlexPLUS(TM) can be used as a hybrid system to protect a 'sick' level above or below a fused level. Additionally, the implantation of FlexPLUS(TM) requires no special instrumentation or protocol."

FlexPLUS(TM) offers several types of rods composed of titanium and polymer, all fully compatible with P.L.U.S.(R) and X-P.L.U.S.(TM) screws and instruments, and can of course be used in combination with PediGuard(TM) for optimal placement of the pedicle screws.

PediGuard(TM) is the world's first and only wireless freehand drilling instrument to detect inadvertent breach in the pedicle, thus resolving the well-documented challenge of placing vertebral screws safely within the spine, without having to change the surgeon's technique, and reducing X-ray exposure to patients and operating room staff.

Until now, PediGuard(TM) had been available with two different shapes of tip, a 4-edged and a Tri tip, both in 3.2mm and 4.0mm diameters. The feedback from surgeon users has shown a clear preference for the sharper Tri tip, and a strong enthusiasm for the development of a smaller diameter.

"We are proud to announce that the use of PediGuard(TM) will now be possible for surgeons wishing to use a smaller diameter tip, either because it corresponds to their surgical habits, or because they are facing most challenging pedicles, for example in adult cervical or pediatric thoracic cases. We believe that the 2.5mm-diameter Tri tip PediGuard(TM) has tremendous potential, as a unique solution in cases where the size, or the distortion of the pedicles, makes it even more difficult to safely place pedicle screws," said Julian Mackenzie, SpineVision's Chief Executive Officer.

About SpineVision

SpineVision (http://www.spinevision.com) is an innovative medical device company focused exclusively on developing and marketing implants and instrumentation for application in spinal surgery.

  •      FlexPLUS(TM) is not available in the USA

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Ronald Trahan
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