Business Overview 2006 - Synthes

Product Highlights. Spine
Spine. SynFix-LR
SynFix-LR is an innovative device for the fusion of the lumbar spine. As this implant is inserted and fixated
from the front, the delicate back muscles are not affected and patients recover more rapidly. And because only
one surgical approach is necessary, the procedure is more efficient, saving time and costs.
It is well established that at least 8 out of 10 people experience a significant
and disabling episode of back pain at some stage in their life.
These episodes are likely to occur between the ages of 30 and 50,
the most productive period of most people's lives. As we get older,
certain biochemical and structural changes occur in our intervertebral
discs, which can cause pain. Symptoms generally settle spontaneously
within 6 to 12 weeks, but in some cases symptoms persist
and result in considerable limitations affecting work and recreational
and domestic activities.
Approximately one percent of this patient group with persistent and
debilitating pain undergoes surgery to relieve the symptoms. And of
these operated patients around 10 percent are found to have localized
mechanical pain or pain originating from the intervertebral disc
and subsequently undergo a spinal fusion. This involves removing the
pain-generating disc and placing a vertebral spacer between the adjacent
vertebral bodies. The affected segment is additionally fixated
by posterior pedicle screws combined with rods. This requires more
than one incision for accessing the spine from different angles (also
known as 360° fusion).
SynFix-LR stand-alone solution: single
approach from anterior only
Less invasive surgery – faster recovery
360° degree fusion: two approaches
from anterior and posterior
Since SynFix-LR is inserted anteriorly, the posterior muscular structures
are preserved and surgical morbidity associated with posteriorly
instrumented lumbar spine fusion surgery is eliminated. Additionally,
SynFix-LR does not have any overlaying profile on the anterior spinal
column. The postoperative risk of damaging vessels and soft tissue is
therefore eliminated. As a result, patients can be mobilized earlier
and leave hospital sooner, reducing expenses for the hospital stay.
Opening up new options in spinal fusion
Most implant devices require a posterior approach – that is, the surgical
procedure is performed from the back. Posterior approaches
involve cutting through lumbar muscles which are important in maintaining
an upright posture and supporting the spine during day-today
activities. The muscles can take a long time to recover, and the
disruption to their normal mechanics can lead to complications for
quite some time after the operation. Synthes has developed a device
that can be applied from the front (anteriorly) by means of a less invasive,
muscle-sparing approach. SynFix-LR consists of a radiolucent
cage and an integrated plate which is fixated with diverging locking
screws for superior stability and pull-out resistance. Together, the fixation
plate and the locking screws act as a tension band. Biomechanical
tests have demonstrated that SynFix-LR offers stability comparable
to that of a cage combined with posterior pedicle screws in flexion,
extension and lateral bending, and is superior in axial rotation.
SynFix-LR requires only a single anterior approach to restore the disc
height and lordotic angulation and fixate the implant. Moreover, Syn-
Fix-LR is a stand-alone device, so additional fixation devices for stabilizing
the affected spine segment are not necessary. Consequently,
surgery time is considerably shorter than in methods involving cages
applied in combination with pedicle screws and rods. Less time in the
operating theatre means a direct reduction of OR-related and staff
costs.
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