NEW YORK, Dec. 15, 2006 (PRIME NEWSWIRE) -- Paradigm Spine, LLC, a developer of innovative posterior non-fusion spinal implant solutions, announced that it has received a European Union CE Mark for its coflex-F(tm). The CE Mark will allow Paradigm Spine to begin marketing the coflex-F(tm) in Europe and many countries around the world that recognize the certification.
Coflex-F(tm) is an interspinous fusion device intended for use as an adjunct to lumbar fusion in skeletally mature patients with clinically symptomatic one- or two-level degenerative disc disease (DDD) from L1-L5.
Coflex-F(tm) is an indication-specific evolution of Paradigm's coflex(tm), a dynamically functional non-fusion interspinous implant used in the treatment of moderate to severe spinal stenosis, and currently undergoing an FDA-approved clinical trial in the United States.
The coflex-F(tm) system, including implants and instruments, was developed with a surgeon team to specifically address the needs of patients suffering from DDD. Coflex-F(tm) is intended to provide a level of segmental spinal stabilization similar to that of pedicle screws, but less invasive, tissue sparing and preserving pedicle anatomy.
Marc R. Viscogliosi, Chief Executive Officer of Paradigm Spine, said, "This milestone demonstrates our commitment to developing a comprehensive portfolio of spine non-fusion products.
"Although coflex-F(tm) is a fusion product, the intended application, with its unique features and benefits, may assist in reducing the long-term incidence of adjacent segment degeneration in DDD patients," he added.
Coflex-F(tm) becomes Paradigm's third product to receive a CE Mark, including coflex(tm) and the Dynamic Cervical Implant (DCI), which received CE Mark on December 5, 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 38 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
The Paradigm Spine, LLC logo is available at http://www.primenewswire.com/newsroom/prs/?pkgid=2929