FDA Pediatric Clearance For Medicrea’s PASS® LP Scoliosis System

In sh0rt

French Spinal device company MEDICREA group has announced the FDA approval of its PASS® LP system for the treatment of adolescent idiopathic scoliosis. The PASS® LP is the lowest profile pedicle screw spinal fusion system available on the market and has been designed to address the most complex spinal pathologies making it specifically adapted to pediatric indications.

Background

Based in Lyon France, MEDICREA specializes in the design, development, manufacture and distribution of orthopedic implants dedicated to spinal surgery.

The company’s PASS® LP thoraco-lumbar fixation system allows connection of the rod at a distance from the spine and performs a 3D correction of the deformity through gentle and progressive stress distribution on all anchorages using the ST2R technique (Simultaneous Translation on 2 Rods). Through its proprietary derotation connectors & technique, the PASS LP offers a unique way to achieve correction of the deformity in all planes. Derotation in the coronal plane is obtained with no risk of screw ploughing or pull-out, while preserving sagittal balance, essential in the treatment of adolescent idiopathic scoliosis.

Company comments

“Medicrea is deeply committed to advancing care for scoliosis patients and we have developed technologies like PASS LP to put new capabilities into the hands of surgeons who treat the most complex spinal deformities,” stated Denys SOURNAC, MEDICREA’s President and CEO. “ We are extremely pleased to announce the approval for this new indication.”

Source: Medicrea Group, Business wire