2014

Paradigm Spine Receives CE Mark for DSS(TM) Dynamic Stabilization System Company's fourth non-fusion product to receive EU approval



    NEW YORK, April 30 /PRNewswire/ -- Paradigm Spine, LLC, a developer of
 innovative non-fusion spinal implant solutions, announced that it has
 received a European Union CE Mark for its DSS(TM) implantable dynamic spine
 stabilization system. The CE Mark will allow the company to begin marketing
 the DSS(TM) system in Europe and many other countries that recognize the
 certification.
     The first surgery involving the DSS(TM) system was performed on April
 27th, 2007 in Straubing, Germany by Dr. Rudolf Bertagnoli.
     The DSS(TM) system is a pedicle-screw based, implantable dynamic spine
 stabilization system indicated for degenerative disc disease (DDD) of the
 lumbar spine. The DSS(TM) system incorporates a hybrid philosophy,
 combining elements of fusion and motion preservation.
     The system was developed over a two-year period in close cooperation
 with Professor Hans-Joachim Wilke, a world-renowned Professor of
 Biomechanics from the University of Ulm in Germany, and Dr. Bertagnoli, the
 most experienced spine arthroplasty surgeon worldwide.
     The modularity of the DSS(TM) system enables the combination of DSS
 dynamic couplers with DSS fusion couplers at adjacent levels. Therefore,
 one segment may have functionally dynamic stabilization (non-fusion) while
 an adjacent segment has rigid segmental fixation (fusion) under the same
 system.
     The DSS dynamic coupler increases the stiffness of the affected motion
 segment and restricts the range of motion in flexion, extension, lateral
 bending and rotation while preserving motion. By selecting the appropriate
 size DSS dynamic coupler, the posterior segmental height can also be
 adjusted. The DSS fusion coupler provides rigid segmental fixation
 utilizing the same instrument set. One of the features and benefits of the
 system is the use of percutaneous screw positioning that facilitates a
 minimally invasive muscle- sparing approach.
     Marc R. Viscogliosi, Chief Executive Officer of Paradigm Spine, said,
 "The DSS(TM) system is the product of collaborative thinking between two of
 the world's most experienced spine motion-preserving experts, from both a
 scientific and clinical point-of-view."
     "The DSS(TM) system is one of the first truly dynamic stabilization
 systems because it increases segmental stiffness while controlling specific
 ranges of motion as the patient goes about his or her daily activities," he
 noted. "We are particularly excited to have benefited from the enthusiastic
 development efforts and significant contributions of Professor Wilke and
 Dr. Bertagnoli."
     Professor Wilke said, "I worked very closely with the Company on
 incorporating the key strategic and scientific elements of the ranges and
 types of motion which need to be controlled by a true dynamic stabilization
 system. Specifically, we designed the system to focus on controlling
 'active zone' motions, which are normally associated with pathologic
 painful arcs of motion."
     Professor Wilke further added, "This product reflects what we have
 learned about the function of the human spine from multiple spine
 experiments over many years, based on studies conducted with our validated
 Finite Element model of a lumbar spinal segment."
     Dr. Bertagnoli said, "The surgery on Friday [April 27] went very well
 and I believe the DSS(TM) system has the potential to become an important
 new option in the continuum of spine care. Having used most of the major
 spine arthroplasty products I, like Professor Wilke, am convinced of the
 uniqueness and potential impact of the DSS(TM) system for the treatment of
 my patients."
     The DSS(TM) system is Paradigm Spine's fourth product to receive a CE
 Mark, following the coflex(R) interspinous implant, the DCI(TM) dynamic
 cervical implant, which received the CE Mark on December 5, 2006; and the
 coflex-F(TM) implant system which received the CE Mark on December 15,
 2006.
     About Paradigm Spine, LLC
     Paradigm Spine is a company focused on providing indication specific
 posterior non-fusion solutions for orthopedic spine surgeons and
 neurosurgeons focused on treating spinal conditions and diseases.
     The company's founding philosophy is "Surgeon Centric, Indication
 Specific, Data Driven", and focuses on providing the best clinical outcomes
 for patients suffering from chronic back pain. The Company has 40 employees
 at its New York headquarters and office in Wurmlingen, Germany, including a
 7- member direct sales force in Germany.
     The company is concentrating on building a multi-product non-fusion
 portfolio. The company's signature product is the coflex(TM) posterior,
 non- fusion interspinous dynamically-functional implant. The company has
 commenced a multi-center IDE clinical trial of the coflex(TM) implant in
 the United States.
     Paradigm Spine's other core platform is the Orthobiom(TM) technology
 which has been in development for over a decade. The Orthobiom(TM)
 technology treats adolescent idiopathic scoliosis, a condition that causes
 severe curvature of the spine that can be corrected surgically through a
 spinal fusion procedure. The Orthobiom(TM) system is a non-fusion
 alternative designed to preserve the motion and growth of the child's
 spine. It is regarded as a revolutionary product with the potential to help
 the tens of thousands of children diagnosed annually with scoliosis.
     Paradigm Spine, LLC was founded in 2004 by Viscogliosi Brothers, LLC.
 (VB). Established by Marc R. Viscogliosi, John J. Viscogliosi and Anthony
 G. Viscogliosi in New York City, in 1999, VB is the first venture
 capital/private equity and merchant banking firm dedicated to the $26.4
 billion musculoskeletal/orthopedics device sector of the health care
 industry.
     Today, VB is a leading independent firm, with a mission to create,
 build and finance companies founded on innovations developed by surgeons
 and uniquely focused on "life-changing" musculoskeletal/orthopedic
 technologies. VB has worldwide surgeon, industry and trade relationships
 and significant financial expertise in the musculoskeletal/orthopedic
 sector.
     For more, visit: www.paradigmspine.com
 
 

SOURCE Paradigm Spine, LLC

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