MEDICREA PASS® LP ILIAC FIXATION RECEIVES FDA CLEARANCE
MEDICREA® 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.
MEDICREA specializes in the design, development, manufacture and distribution of orthopedic implants dedicated to spinal surgery. In an $8 billion market, which is growing at a rate of 15 % per annum, MEDICREA enjoys an excellent reputation and benefits from unique relationships with highly-skilled spine French and US surgeons. Products developed, patented and manufactured by MEDICREA provide surgeons with new and less invasive surgical solutions, which are faster and easier to implement than traditional techniques. The Group operates from its headquarters based in Lyon, France with a manufacturing facility located in La Rochelle, France and three distribution subsidiaries in the USA, UK and France.
ISIN code : FR 0004178572
MNEMO code : ALMED
For more information, visit www.medicrea.com
Denys Sournac , Chief Executive Officer
Tel : +33 (0)4 72 01 87 87 - firstname.lastname@example.org
Fabrice Kilfiger , Chief Financial Officer
Tel : +33 (0)4 72 01 87 87 - email@example.com
Analysts investors and press relations
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