Alzenau, October 24, 2016. In august SIGNUS announced the 510(k) clearance
from the United States Food and Drug Administration (FDA) for their new
DIPLOMAT pedicle screw system.
The DIPLOMAT has been developed in cooperation with international spine
experts. As a posterior fixation system it provides user-friendly and reliable
instrumentation for all spine treatments.
“The main focus of DIPLOMAT is the optimized balance between clinical performance
and user-friendliness,” says SIGNUS Managing Director, Uwe Siedler. The
system combines maximal clinical efficiency with all the important properties
required for optimal patient treatment.
The pedicle screws are a modular two-piece implant: depending on the indication
and surgical application, the pedicle screws can be assembled as required
with the appropriate tulips. If necessary, the tulips can be removed and replaced
in situ during surgery. A very low tulip profile of only 14.9 millimeters
guarantees optimal anatomical alignment and prevents any protrusion of the
tulip even in slim or young patients. The patented ELASTOLOK® locking mechanism
ensures the highest strength for the screw/tulip connection. The DIPLOMAT
system provides optimal flexibility and efficiency thanks to these features.
DIPLOMAT impresses users not only with its high level of safety but also with
its ease of handling during surgery. All the pedicle screws are cannulated, as
well as being fenestrated from a diameter of 5.5 millimeters. The comfortable
screw-cannula diameter of 1.9 millimeters also allows the use of stronger guide
wires, which noticeably stabilizes the insertion of the pedicle screw during MIS
procedures. The DIPLOMAT pedicle screws have a self-tapping double thread
that provides the best possible fixation and perfect anchoring in the bone. The
high thread pitch enables faster insertion which considerably shortens surgery
time.
SIGNUS provides a complete selection of DIPLOMAT system components all with a sophisticated design. When treating long segments of the spine, innovative telescopic cross-connectors secure the instrumentation while parallel connectors allow for simple subsequent treatments with varying rod diameters. The system rods are available both as titanium and as cobalt-chrome components to suit different demands.
Despite the versatility of the instruments, in routine clinical use the outlay and costs remain reasonable. DIPLOMAT is arranged in only two containers, which is a significant reduction in time spent on logistics and reprocessing in the hospital.
further information DIPLOMAT®
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For more information on DIPLOMAT please visit: www.signus.com
Brief profile of SIGNUS
SIGNUS Medizintechnik supports surgeons and medical professionals by
providing innovative and safe solutions for the treatment of spinal disorders –
to give patients the best possible mobility in their daily routines. Commitment
creates trust: Our years of experience and comprehensive expertise give us a
clear understanding of the needs of medical experts and patients. This enables
us to quickly transform new requirements into reliable, premium-quality
products. This has been our goal as a family-run company since 1994.
Published at SIGNUS Press Release
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