DRIEBERGEN, Netherlands, October 25 /PRNewswire/ --
- New spinal device proves to be a viable alternative for surgeons and patients
Pioneer Surgical Technology BV, a leading innovator in the design and manufacture of spinal implants, presented two year clinical results of its NUBACTM Disc Arthroplasty System at the recent Europe Spine Society meeting in Brussels, Belgium. Results showed significant improvement in spine related symptoms, such as disability and pain, and absence of surgery related complications. NUBAC, a new motion preservation device, is a potentially tissue preserving and less invasive alternative to current spinal procedures.
Back pain impacts millions of people worldwide. Degenerative disc disease (DDD) is believed to be the main cause of low back pain. Until now, patients who suffered from DDD had limited alternatives to total disc replacement / arthroplasty (TDR / TDA) or spinal fusion surgery. Although these procedures relieve pain, side effects such as surgery related complications, invasiveness and revision risk have called the need for more non-fusion technologies. In the development of the NUBAC device, benefits and pitfalls of fusion and TDA have been taken into account and are now showing their first results.
Encouraging clinical results
A prospective longitudinal multi centre clinical study was initiated to examine the safety and efficacy of NUBAC within patients with symptomatic 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 over 100 patients. No major intra-operative neurological or vascular complications occurred. Patients were evaluated before as well as at several stages after the operation using self assessment tools to measure permanent functional disability (Oswestry Disability Index (ODI)) and pain (Visual Analog Scale (VAS)). Also, SF 36 (Short-Form General Health Survey, measuring aspects of the quality of life of patients) and radiographic data were collected before and at several stages after the operation. Patients reported significantly fewer pain symptoms and lower levels of disability compared to preoperative measurements. Radiographic examination showed that the index height and range of motion (ROM) were maintained compared to before the operation.
Lex Giltaij, MD of Pioneer Surgical Technology said, "We are excited about these encouraging clinical results. The improvement in function and pain scores and the absence of any major intra-operative and post-operative vascular or neurological complications show the potential of the NUBAC to be a viable, first line surgical treatment option for use in patients with low back pain caused by DDD."
Massimo Balsano, MD, Director of Spinal Department of the Hospital of Thiene-Schio, Vicenza, Italy stated, "We have been waiting for advances in non-fusion technology for a long time. We are therefore proud to be participating in this clinical study and to offer physicians and patients less invasive procedures such as the NUBAC device."
The clinical evaluation of NUBACTM Disc Arthroplasty System is ongoing.
NUBACTM Disc Arthroplasty System
NUBACTM Disc Arthroplasty System is a unique device, designed for patients with early to moderate degenerative disc disease (DDD). NUBAC aims to be tissue preserving and less invasive than other surgical treatments. It is intended to relieve low back pain and maintain the patient's natural motion and disc height. It also is designed to reduce surgery time and recovery and avoid bridge burning. NUBAC is a two piece design with an inner ball and socket articulating joint, manufactured from polyetheretherketone (PEEK) material.
NUBAC is now available in several countries in Europe, amongst others the UK, Germany and Italy. In the United States, the NUBACTM Disc Arthroplasty System is being implanted as an investigational device in accordance with FDA requirements.
Pioneer Surgical Technology in Europe
Pioneer Surgical Technology's European subsidiary was established in the Netherlands in August 2006 following the introduction of NUBACTM in Europe. Pioneer works with distributors in eight countries in Europe, amongst which the UK, Italy, Switzerland and the Netherlands. Pioneer is building up its own sales team in Germany. European headquarters are located in the Netherlands and are headed up by Lex Giltaij, M.D., with over 16 years of experience in international business, sales and marketing management, and product and business development in the orthopaedic and spinal medical device, biotech, and pharmaceutical industries.
For more information about Pioneer Surgical Technology and the full range of spine products, see: http://www.pioneersurgical.eu/.
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 innovation and has been awarded 30 patents. It is a true surgeon-driven spinal device company that promotes responsiveness through customer intimacy, surgeon-to-surgeon relationships.
Pioneer Surgical Technology carries a full portfolio of spinal products with the Quantum(R) Spinal Rod system, Vertebral Body Replacement Devices and the Pioneer(R) 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 employs more than 250 employees worldwide.
Web site: http://www.pioneersurgical.com
 The ODI score improved from 50.4 preoperatively to 10.3 after 24 months. VAS scores decreased from 76.6 preoperatively to 23.5 after 24 months. For more detailed scores and an extract of the clinical study, see: Spinal Surgery News, October 2007.
Lex Giltaij, MD (VP Europe & Business Development) of Pioneer Surgical Technology, +31-30-693-4720, email@example.com; or Harald Simons, Fleishman-Hillard Amsterdam, +31-20-406-5930, firstname.lastname@example.org, for Pioneer Surgical Technology BV