Devices Neurosurgery Orthopaedic FDA

 News Release - May 6, 2008

Scient'x Announces FDA 510(K) Clearance for Isobar DUO(TM) Dynamic Stabilization System

MAITLAND, Fla., May 6 (HSMN NewsFeed) -- Scient'x, a privately held manufacturer of innovative spinal implant technologies, announced today that they have received FDA 510(k) clearance to market their new Isobar DUO(TM) Dynamic Stabilization System. This system is an extension of the original Isobar Dynamic TTL-Rod® which received FDA 510(k) clearance in 1998. The Isobar Duo(TM) has been cleared to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment; fracture, dislocation, scoliosis, kyphosis, spinal tumor; and failed previous fusion. The development of this system originated directly from surgeon requests to utilize the Isobar Dynamic TTL-Rod® technology at multiple levels. With the Isobar Duo(TM), the surgeon is able to utilize a standard 5.5mm diameter rod with two unique dampener elements that provides controlled motion for use at two levels.

Michael Huggins, CEO of Scient'x, said today, "The FDA 510(k) clearance of the Isobar Duo(TM) system combined with the repurchase of the license agreement on the Isobar Dynamic TTL-Rod® from Alphatec will allow Scient'x to strengthen its leading position in the dynamic stabilization spinal implant market." With over 10,000 implants worldwide, Scient'x has the longest clinical track record with dynamic technologies of any spinal implant company. Now 20 years old and the largest independent spinal implant company outside of the USA, Scient'x has been first to market with PEEK implants, first with dynamic rod systems, first with the plate-cage concept, and first with a ceramic cervical disc prosthesis.

Based in Paris, France, Scient'x, S.A. is the largest independent spinal implant company in Europe. The Company designs, develops and distributes an extensive line of spine surgical implants in over 50 countries around the world. Since 1988, Scient'x has been a pioneer in all aspects of spinal instrumentation including the motion preservation segment of the spine market. The Company was the first to introduce PEEK implants to spinal surgery as well as posterior dynamic stabilization technology. Scient'x has now introduced a second generation ceramic cervical disc that has achieved significant revenue traction and surgeon acceptance in Europe. Scient'x is a privately held company. For more information about the company, please visit www.scientxusa.com.

Source: Scient'x

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