PASS LP spinal system for treating complex deformities receives FDA approval

Sep 4 2009

MEDICREA® (Paris:ALMED) announced today it has received clearance from the U.S. Food and Drug Administration (FDA) to market the PASS® LP Iliac Fixation within the United States. This new Iliac Fixation supplements the PASS® LP range, a ultra Low Profile Polyaxial Spine System launched recently.

The PASS® LP Spinal System includes polyaxial anchorages such as pedicle screws, sacral plates, hooks/claws, rods/rod-plates, sacral/iliac screws and a UNIQUE variety of active connectors that permit realignment of vertebrae (fracture) or correction of vertebral axial rotation (full 3D correction of a deformity).

The PASS® LP Spinal System is ideal to treat long or complex deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis). Adequate reduction can be achieved by evenly distributing forces applied to both rods at the same time thus limiting excessive load and stress on the anchorage points. 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.

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.

“The launch of the PASS® LP Iliac Fixation, developed in collaboration with leading U.S. Surgeons, will increase significantly PASS® LP sales in coming months as it allows MEDICREA to complete its product line for deformity treatment - an over 400$ million segment out of the 6,5$ billion total US market for spinal implants", says Denys Sournac, President and CEO of MEDICREA.

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.