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Technology already has been in use in the European Union.
August 11, 2015
By: Chris Delporte
Officials with Rockaway, N.J.-based LinkSpine, a developer of less-invasive implants for spinal surgery, report the first U.S. implantation of the FacetLink Mini device. The Mini uses two screws and an expandable cross-connector assembly to stabilize the lumbar spine following a tissue-sparing midline decompression. Dhruv Pateder, M.D., an orthopedic spinal surgeon, performed the procedure at HCA Reston Hospital Center in Reston, Va. “Using a minimally invasive technique, FacetLink Mini allows rigid posterior spinal column fixation with only two cross-linked lag screws instead of a traditional, open pedicle screw and rod construct where four screws are needed,” said Pateder. “The device is quickly and efficiently placed utilizing a very intuitive surgical technique. The patient is doing great and was discharged the next day.” Massimo Calafiore, president of LinkSpine said: “FacetLink Mini fits within the bounds of a midline decompression exposure, requiring no additional dissection beyond what was planned for the decompression itself. This is based upon the medial to lateral screw trajectories which anchor the devices to the bone, and the need for just two screws to complete a one level construct.” Dennis Farrell, vice president of marketing and product development for the company added: “The early clinical experience in the E.U. (European Union) has been very encouraging, with 80 cases performed over the past 30 months. We are excited to build upon this experience here in the U.S. as we continue to work towards the possibility of improving patient outcomes through simple, less-invasive surgical techniques.” FacetLink Mini is manufactured from titanium and is designed for placement in the setting of a bilateral decompression through bilateral laminotomies. It is anchored with trans-articular pedicle screws that cross the facets, pin the joints, and terminate at the base of the pedicle. An adjustable monorail rigidly connects the screws for additional stability. The Facet-Link Stabilization Platform is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The system is indicated for use with bone graft, at single or multiple levels, from L3 to S1 (inclusive). The platform is indicated for the treatment of any or all of the following: spondylolisthesis; degenerative disc disease as defined as back pain of discogenic origin as confirmed by radiographic studies; and degeneration of the facets with instability. This video shows the FacetLink Mini in action.
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