Premia Spine
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The TOPS™ System is a mechanical device that is housed between two titanium plates, which allows axial rotation, lateral bending, extension, and flexion. The implant facilitates bending, straightening and twisting movements at the affected segment of the spine while blocking excessive posterior and anterior sagittal translation.
The TOPS™ System effectively replaces the anatomical structures, such as the lamina or the facet joint that are removed from the vertebrae during the spinal decompression treatment to alleviate pain. For example, the internal metal stoppers replace the natural bony elements that served as stoppers during axial rotation. The boot and internal components take the place of the supraspinous ligament, interspinous ligament, and ligamentumflavum in their ability to help control flexion. The internal metal stoppers replace the natural bony elements that served as stoppers during axial rotation. As with spinal fusion devices, the TOPS System is anchored to the spine with four standard polyaxial pedicle screws and is implanted via a traditional posterior surgical approach. However, the TOPS System’s unique patented crossbar configuration exerts less force on the screws than typical fusion implant devices place on their fasteners. If you have symptoms of spinal stenosis, talk to your physician options about all your treatment options, and find out if Posterior Arthroplasty is the right solution for you. |
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The TOPS™ System recreates motion in all directions – flexion, extension, lateral bending, and axial rotation. Clinically proven to provide immediate and sustained pain relief and improvement in quality of life, Premia Spine’s TOPS™ System has also been demonstrated to provide better outcomes than lumbar spinal fusion surgery for appropriate patients. The TOPS System provides three major benefits for the treatment of spinal stenosis. First, the procedure stabilizes the posterior spine and reestablishes a controlled range of movement. Second, patients regain their ability to bend, flex, walk, and enjoy the normal activities of life. Third, and most importantly, patients experience immediate and sustained pain relief. Clinical studies conducted since 2005 show the TOPS System alleviates persistent leg and low back pain for patients with moderate to severe spinal stenosis with or without spondylolisthesis (a slipped disc) and facet arthrosis (bone spurs). Do you have symptoms of spinal stenosis? Click on the testimonials to hear from people who suffered as you do. And talk to one of our doctors about all your treatment options, and find out if Posterior Arthroplasty is the right solution for you. |
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Indications For Use Degenerative spondylolisthesis refers to an abnormal alignment with slippage of one spinal vertebra in relation to another that can cause pain in the lower back and legs. This condition can often occur concomitantly with a narrowing of the spinal canal, compression of the traversing nerves, and also increased abnormal movement of the two vertebrae in relation to each other. The TOPS™ System is intended to provide stabilization following decompression in skeletally mature patients with disease at one level from L3 to L5 who have not achieved sufficient symptom relief with prior conservative care. |
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Attaining Superior Clinical Outcomes for Surgical Decompression Patients Patients have a new treatment option for spinal stenosis, spondylolisthesis, and debilitating pain in the lower back and legs. The TOPS™ System, a mechanical implant device, offers a superior surgical alternative to spinal fusion back surgery for patients with moderate to severe lumbar spinal stenosis and related spinal conditions. TOPS Posterior Arthroplasty addresses two critical functions of the spine – maintaining stability and preserving motion. In a Posterior Arthroplasty procedure, the surgeon removes the bony elements that press on nerves. Thereafter, the doctor implants the TOPS System to stabilize and reestablish a controlled range of movement of the posterior spine, which enables patients with symptoms of spinal stenosis including lower back pain, sciatica, and pain in the legs while walking (spinal claudication) to regain their ability to bend, flex, walk, and enjoy the normal activities of life that were so painful before surgery. |
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Providing More Flexibility in the Treatment of Spinal Stenosis and Spondylolisthesis
The TOPS™ System is a dynamic spinal implant designed to stabilize without fusing the diseased vertebral level following decompression surgery to alleviate pain stemming from spinal stenosis and/or degenerative spondylolisthesis. Spinal stenosis is a narrowing of the spinal canal, which causes a pinching of the spinal cord and nerve roots that extend from the spine to the legs. Degenerative spondylolisthesis refers to an abnormal slip of one spinal vertebra in relation to another that can cause pain in the lower back and legs. The TOPS™ System is indicated for spinal stenosis and spondylolisthesis from L3 to L5. The TOPS™ System can be used in conjunction with Premia Spine's Versalink™ Fixation System to address multi-level diseases of the spine. The Versalink™ Fixation System is intended to treat patients suffering from lumbar spinal disease at one or two adjacent levels between L1 and S1 that requires decompression and stabilization by fixation.
Pain relief is typically achieved when the surgeon removes the bone elements that press on the nerves. Upon completing the decompression, the surgeon implants the TOPS System to replace the extracted skeletal structures and stabilize the spine. With the TOPS™ System, clinicians can remove all elements pressing on nerve roots without concern for leaving enough bone for fusion to occur. Instead of permanently locking two adjacent vertebrae, clinicians allow the two vertebrae to continue moving normally with the assistance of the TOPS™ implant. |
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The TOPS™ System allows full motion at the operative level, while prohibiting excessive twists and turns. The result is motion preservation, optimum decompression, spine stability, and pain relief. Patients typically experience immediate pain relief post-surgery. Most patients are on their feet and walking the next day, and claim they haven't felt pain-free in years. As there is no fusion taking place in the lower back with the TOPS™ System, there are few restrictions on activity. Full recuperation varies from patient to patient. However, you can expect in most cases to experience an immediate benefit and then progressive improvement as you undergo a strengthening and rehabilitation program. |
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