Healthcare Industry News: S.A.
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 S.A.ilization System. This system iS.A. 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 S.A.ilization of spinal segments in skeletally mature patientS.A. an adjunct to fusion in the treatment of the following acute and chronic inS.A.ilities 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.A.le to utilize a S.A.dard 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 S.A.ilization 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.A.d distributeS.A. extensive line of spine surgical implants in over 50 countrieS.A.ound 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 S.A.ilization technology. Scient'x has now introduced a second generation ceramic cervical disc that haS.A.hieved 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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