LYON, France–(BUSINESS WIRE)–MEDICREA® (Paris:ALMED) announced today the launch of the PASS® LP De-Rotation connector on the U.S. market, and the preparation of a U.S. prospective multicenter clinical study analyzing the 3D correction of adolescent idiopathic scoliosis by posterior instrumentation.
PASS® LP Spinal System unique technique allows to treat long and complex deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis). The rods are pre-bent to the desired curve in the sagittal plane. Progressive reduction of the deformity is achieved by alternately tightening all the nuts on both rods at the same time thereby significantly reducing the stress applied on the screws and hooks compared to other fixation systems on the market.
Thanks to the adjunct of the De-Rotation Connector in the PASS® LP Spinal System, the correction technique now allows, without applying any additional stress on the spine and not requiring any specific instruments, a significant correction of vertebral axial rotation leading to the full 3D correction of the deformity.
The aim of the study is to evaluate the clinical, functional and radiographic outcomes following the reduction of adolescent idiopathic scoliosis using PASS® LP system and its De-Rotation Connector.
The study will begin early in 2010 and the complete follow up period will last 3 years.
The first clinical results will be published end of 2011.
The PASS® LP Spinal System is also indicated for degenerative disc disease (ddd), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudoarthrosis and failed previous fusion.
MEDICREA acting on the U.S. market only since 2007 and having already a major sales growth since then (1.9$ million in 2007, 3.6$ million in 2008 and around 8.5$ million out of 18$ million estimated group sales for 2009), expects a significant revenue increase next year as other new and innovative products should be launched soon.