Business Overview 2006 - Synthes

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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. 22
Synthes. Annual Report 2006 Patient story | This 32-year-old Australian mother of two children suffered from increasing back and leg pain. At first, she opted for conservative treatment, but after a year she could no longer tolerate the pain and the limitations to her domestic activities. Still, she did not like the idea of having ”nuts and bolts” put in her back. When she heard of the new SynFix-LR device, she was so convinced that it was the solution that she decided to wait another 6 months until the implant was available. She was one of the first patients worldwide to be treated with SynFix-LR by Dr. C. Cain in Adelaide. The surgery relieved her of her back and leg pain almost immediately. Today, over two years since she underwent this life-changing surgery, she can care for her family without any physical limitations. Pre-operative procedure to identify disc damage After treatment with SynFix-LR 23
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Business Overview 2006 - Synthes

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