Pioneer(R) Surgical Technology\'s NuBac(R) Nucleus Replacement Device ...

Tag : ketone
Pioneer Surgical Technology, Inc. announced, the U.S. Food and DrugAdministration (FDA) granted approval to proceed to IDE PivotalStudy of the NuBac(R) Nucleus Replacement Device for the spine. Pioneer's CEO and Chairman of the Board, Matthew N. Songer, MD, MBAsays, "This is a huge milestone and accomplishment for Pioneer tobe the first to receive FDA approval to start the IDE pivotal studyfor nucleus replacement. Many other companies, pursuing nucleusreplacement technology, have spent more time and money than Pioneerand have not achieved this significant goal." Songer added, "Thisrecord speed to obtain FDA approval to proceed demonstrates ourdedication to focused innovation and ability to bring new productsto market faster than many of our competitors." The NuBac implant system is the only Nucleus Replacement devicethat utilizes an articulating inner ball and socket design thatseeks to achieve load sharing and uniform stress distribution undervarious physiological loading conditions while minimizing extrusionrisk. The NuBac implant is made of PEEK-OPTIMA(R) material whichoffers well established biocompatibility, biodurability, excellentwear resistance, and radiolucency. Pioneer's Vice President for Advanced Spine, Chip Bao, PhD states,"There are some inherent challenges in the development of nucleusreplacement devices. Pioneer's unique design features of the NuBacimplant have led to a series of successful pre-clinical studies andencouraging results from both the initial U.S. IDE feasibilitystudy and post-market surveillance outside the U.S. under the CEmark." Spinal Disc Arthroplasty surgery includes Total Disc Replacement(TDR) and Nucleus Replacement procedures. Both techniques seek torelieve discogenic back pain caused by degenerative disc disease,restore stability and flexibility to the affected spine segment.Nucleus Replacement procedures are commonly less invasive, moretissue preserving, and less bridge-burning than TDR surgery.Reducing the risk of having to perform revision surgery in thefuture would benefit a much broader population than TDR includingpatients, surgeons, hospitals, and payers. Pioneer's signature, articulating P3(TM) Technology- PioneerPEEK-on-PEEK- is the heart of the NuBac design. The company's otherP3 motion preservation products are the NuNec(TM) artificialcervical disc and the BacJac(TM) interspinous decompression system.All three products are currently available in Europe under CE markand provide patients and surgeons with the most technologicallyadvanced designs in the industry. Earlier this year, Pioneer announced significant findings on theeffect of accelerated aging on the wear of PEEK(Poly-ether-ether-ketone). The study, conducted in collaborationwith RUSH University in Chicago, determined that wear properties ofPEEK-on-PEEK are not susceptible to the effects of acceleratedaging. The study bolsters support for the long term durability ofthe company's P3 designs. About Pioneer Surgical Technology Pioneer Surgical Technology, Inc., headquartered in Marquette,Michigan, is a dynamic medical device firm with a full line ofcutting-edge motion preservation devices, either availablecommercially in Europe or under clinical evaluation in the U.S.Pioneer's signature articulating P3(TM) Technology - PioneerPEEK-on-PEEK, in its NuBac(TM) disc arthroplasty system, BacJac(TM)interspinous decompression system, and NuNec(TM) artificialcervical disc, is the most technologically advanced in theindustry. Currently, Pioneer offers a diverse portfolio of nextgeneration spinal fusion devices. Pioneer's focus on innovation hasresulted in over 100 U.S. and Foreign patents with numerous patentspending. The company established a Biologics Division following twoacquisitions in 2007. Pioneer Orthobiologics is developing a richpipeline of products indicated for a variety of spinal andorthopaedic applications. Pioneer focuses on developing productswhich are easier and faster for the surgeon, cost effective for thehealth care system, and provide better patient outcomes. Pioneer Surgical Technology, Inc. http://www.pioneersurgical.com