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
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
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
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
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,
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
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
For more, visit: www.paradigmspine.com
SOURCE Paradigm Spine, LLC