Pioneer Surgical Technology Begins NUBAC Intradiscal Arthroplasty(TM) System U.S. Clinical Trials for Patients With Degenerative Disc Disease.MARQUETTE, Mich. -- New Motion Preservation Device is Designed to Offer Less Invasive Alternative to Total Disc Replacement and Spinal Fusion spinal fusion n. A surgical procedure in which vertebrae are joined. Also called spondylosyndesis. Spinal fusion Treatments Pioneer Surgical Technology, a leading innovator in the design and manufacture of spinal and orthopaedic implants, today announced the first implantations of the NUBAC Intradiscal Arthroplasty(TM) System in the United States as part of its Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) study. NUBAC(TM) is the only intradiscal arthroplasty device for patients with degenerative disc disease Degeneration of the intervertebral disc, which is often called "degenerative disc disease" (DDD) of the spine, is a common disorder of the lower spine and for some people can cause low back pain and/or leg pain (sciatica). utilizing articulating PEEK-on-PEEK material designed to achieve load sharing and uniform stress distribution under various physiological loading conditions. Patients are expected to benefit from a less invasive spinal treatment option that is intended to reduce surgery time, speed recovery, and increase flexibility. Dr. Matthew Songer successfully implanted the NUBAC(TM)devices in patients with degenerative disc disease at Marquette General Hospital Marquette General Hospital is a hospital and regional medical center located in Marquette, Michigan and serving the Upper Peninsula of Michigan. Marquette General Hospital Website in Marquette, Michigan. "This collaboration in the front-line trial for NUBAC(TM) at Marquette General is an opportunity for patients in our region to receive spinal repair that is not available anywhere else in the United States," said Bill Nemacheck, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Marquette General Health System. "We've developed a forward-thinking regional medical center with an entrepreneurial mindset mind·set or mind-set n. 1. A fixed mental attitude or disposition that predetermines a person's responses to and interpretations of situations. 2. An inclination or a habit. and it is exciting to participate in this trial. We look forward to helping bring another innovative product to patients that will improve their quality of life." The NUBAC Intradiscal Arthroplasty(TM) procedure is intended to preserve most of the annular annular /an·nu·lar/ (an´u-ler) ring-shaped. an·nu·lar adj. Shaped like or forming a ring. annular ring-shaped. tissue while being less invasive than Total Disc Replacement (TDR TDR - time domain reflectometer ) and fusion. The NUBAC(TM) surgical procedure allows further treatment options of TDR or fusion, if revision is required. Principal Investigator Kenneth A. Davenport, M.D., Chief of Staff at Marquette General Hospital, states, "As an orthopaedic surgeon, I have been waiting for advances in non-fusion technology for many years, as fusion often leads to further spinal degeneration at adjacent levels. Although total disc replacement has been a major breakthrough in non-fusion technology, it is limited to invasive anterior surgery and has a fairly high revision risk. I am very glad to see that NUBAC(TM) may offer physicians and patients another less invasive procedure that avoids burning bridges for future surgical options. We are excited to be the first site for the IDE study." "Back pain impacts millions of people worldwide. Degenerative disc disease (DDD DDD Direct Distance Dialing DDD Digital/Digital/Digital (audio CD format, recording/mixing/mastering) DDD Degenerative Disc Disease DDD Domain Driven Design DDD Data Display Debugger (GNU Project) ) is believed to be the main cause of back pain. Until recently, patients who experienced DDD had limited alternatives to total disc replacement or spinal fusion surgery. The development of the NUBAC Intradiscal Arthroplasty (TM) System reflects our continued commitment to be a leading innovator in the design and creation of spinal and orthopaedic products," said Matthew N. Songer, M.D., President and CEO of Pioneer Surgical Technology. "Starting the IDE study for this non-fusion device is a great milestone for patients with DDD and the surgeons who treat them. NUBAC(TM) will improve our overall spinal product offerings and address one of the industry's most pressing challenges; providing less invasive surgical options that treat DDD and preserve lumbar motion." About Pioneer Surgical Technology Pioneer Surgical Technology, headquartered in Marquette, Michigan, is a leading innovator in the design and manufacture of spinal and orthopaedic implants. The company was founded in 1992. The company's first milestone was the development of the Songer Spinal Cable System(R) which provides superior flexibility and strength in spinal fixation procedures. A partnership was later formed with DePuy Spine, formerly AcroMed, to distribute this innovative system. Pioneer developed the Zimmer Cannulated Screw cannulated screw Orthopedics A screw with a hollow shaft, a low pullout strength compared to conventional screws, which can be placed with reasonable precision and minimal trauma using Kirscher ("K") wires Complication CSs may perforate the joint if System using BioDur 108, a new nickel-free stainless steel stainless steel: see steel. stainless steel Any of a family of alloy steels usually containing 10–30% chromium. The presence of chromium, together with low carbon content, gives remarkable resistance to corrosion and heat. alloy. Pioneer has evolved into a true surgeon-driven company, which in 2005 launched the following spinal implant systems: Quantum(R) Spinal Rod, Pioneer(R) Anterior Cervical Plate and its PEEK-Plus Vertebral ver·te·bral adj. 1. Of, relating to, or of the nature of a vertebra. 2. Having or consisting of vertebrae. 3. Having a spinal column. Replacement Devices. Also, NUBAC(TM) received CE approval in 2005. The company is expanding its 70,000 square foot facility in Marquette as it continues to grow its spinal and orthopaedic products. Pioneer currently employs over 200 employees worldwide and has been awarded 30 patents. |
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