Saturday, April 12, 2008

Pioneer Surgical Technology Presents Promising NUBAC Clinical Results - New Spinal Device Proves To Be A Viable Alternative For Surgeons And Patients




Pioneer Surgical Technology BV, a foremost innovator within the guide and make of spinal implant, presented two year clinical grades of its NUBAC� Disc Arthroplasty System at the recent Europe Spine Society gathering in Brussels, Belgium. Results floor show vital expansion in vertebrae connected symptom, such in place of disability and anguish, and nothingness of surgery related complications. NUBAC, a different motion management appliance, be a potentially tissue preserve and lesser amount startling alternative to frequent spinal procedures.



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Encouraging clinical results A prospective longitudinal multi substance clinical examination be initiate to measure the sanctuary and efficacy of NUBAC inwardly patients beside suggestive single-level or double-level DDD in Europe, Latin America and Asia. The clinical study started in December 2004 and since that date, NUBAC devices have been implanted in done 100 patients. No crucial intra-operative neurological or vascular complications occur. Patients be evaluate up and about to that incident moreover as at several section after the operation using self examination tools to arbiter undaunted functional disability (Oswestry Disability Index (ODI)) and pain (Visual Analog Scale (VAS)). Also, SF 36 (Short-Form General Health Survey, measure aspect of the part of duration of patients) and radiographic background were collected before and at several stages after the operation. Patients report to a generous extent a less significant amount of pain symptoms and demean plane of disability compare to preoperative measurements. 1 Radiographic assessment showed that the index altitude and continuum of motion (ROM) were aver compared to before the operation.



Lex Giltaij, MD of Pioneer Surgical Technology said, "We are inflamed in the region of these encouraging clinical results. The improvement in rule and pain score and the absence of any major intra-operative and post-operative vascular or neurological complications show the soon-to-be of the Nubac to be a viable, first strip surgical glare of marketing risk for development in patients with low back pain cause by manner of DDD." Massimo Balsano, MD, Director of Spinal Department of the Hospital of Thiene-Schio, Vicenza, Italy stated, "We have been waiting for advance in non-fusion technology for a drawn out time. We are and so stuck-up to be participating here clinical study and to hold out physician and patients less invasive procedures such as the NUBAC device." The clinical evaluation of NUBACTM Disc Arthroplasty System is ongoing.



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NUBAC is now unspoken for in several pastoral in Europe, amongst others the UK, Germany and Italy. In the United States, the NUBACTM Disc Arthroplasty System is human being implanted as an investigational device in accordance with FDA requirements.



Pioneer Surgical Technology in Europe Pioneer Surgical Technology's European subsidiary was confirmed in the Netherlands in August 2006 consequent the prelude of NUBAC� in Europe. Pioneer works with distributors in eight countries in Europe, amongst which the UK, Italy, Switzerland and the Netherlands. Pioneer is edifice up its particular mart subdivision in Germany. European headquarters are sited in the Netherlands and are head up by Lex Giltaij, M.D., with over 16 years of suffer in developed company, sales and marketing guidance, and article of wholesale and business development in the orthopaedic and spinal medical device, biotech, and pharmaceutical industry.



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About Pioneer Surgical Technology Pioneer Surgical Technology, headquartered in Marquette, Michigan, is a leading innovator in the design and manufacture of spinal and orthopedic implants. Founded in 1992, Pioneer is committed to inventiveness and have been award 30 rights. It is a true surgeon-driven spinal device alignment that push responsiveness through buyer intimacy, surgeon-to-surgeon company.



Pioneer Surgical Technology carry a full portfolio of spinal products with the Quantum� Spinal Rod set of links, Vertebral Body Replacement Devices and the Pioneer� Anterior Cage system. Its' unique NUBACTM Disc Arthroplasty System is CE-marked. The Nubac is not available for sale in the United States and is limited to investigational use in an ongoing IDE study.



Pioneer sign up greater than 250 form worldwide.




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