MEDICREA has received clearance from the FDA to market the PASS LP Iliac Fixation within the US. The new Iliac Fixation supplements the PASS LP range, a ultra Low Profile Polyaxial Spine System.
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 company claims that 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, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, tumor, pseudoarthrosis and failed previous fusion.
Denys Sournac, president and CEO of MEDICREA, said: “The launch of the PASS LP Iliac Fixation, developed in collaboration with leading US 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.