Rockaway,
NJ – LinkSPINE, a company focused upon simple, less invasive implants and techniques for spinal
surgery is pleased to announce FDA (510)k Clearance of FacetLINK. FacetLINK uses two screws and a
novel plated cross-connector assembly to stabilize the spine following a tissue-sparing midline or
microsurgical decompression. The plate assemblies are available in numerous sizes as well as an
expandable version to accommodate various anatomical and pathological scenarios, as well as surgeon
preferences.
Christopher Chaput, MD, an Orthopaedic Spine Surgeon and Director of Orthopaedic Research at Baylor
Scott and White in Temple, TX states, “FacetLINK provides me with an additional tool for treating cases with
mild to moderate instability, where a less extensive exposure is desired. The ability to achieve bilateral
fixation in these cases through the unilateral exposure I work through for my micro-decompression is an
attractive feature to me.”
Faheem Sandhu, MD, Professor of Neurosurgery and Director of Spine Surgery at Medstar Georgetown
Hospital in Washington, DC comments, "the FacetLINK platform offers the option to use a small implant that
secures rigid biomechanical stability, but without the additional tissue exposure required to seat conventional
pedicle screw and rod fixation. This is an attractive alternative for cases with mild to moderate instability."
Helmut D Link, Chairman of LinkSPINE offers, “with our FacetLINK stabilization devices we added a set of
less invasive spinal implants to the spine surgeon’s armamentarium, that are designed to incorporate
important biomechanical lessons learned over decades of involvement in other areas of bone and joint
replacement. We are excited to bring the FacetLINK platform to the US market, and look forward to building
on our experience in reconstructive orthopaedics and spinal prostheses.”
Massimo Calafiore, President of LinkSPINE adds, “FacetLINK fulfills a desire for a simple, less invasive
approach to lumbar spine surgery, adding true value for surgeons who are tiring of long learning curves.”
Dennis Farrell, Vice-President of Marketing and Product Development agrees, “Throughout the course of the
last several years, we have heard several consistent themes from spine surgeons around the world,
including a desire for simple, elegant, and less invasive techniques that allow them to accomplish their
surgical objectives, and the need to focus tightly on patient outcomes. We look forward to working towards
these goals as we begin our clinical experience with FacetLINK in the US.”
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:
1.
Spondylolisthesis.
2.
Degenerative disc disease (DDD) as defined as back pain of discogenic
origin as confirmed by radiographic studies.
3.
Degeneration of the facets with instability.
For
more information about LinkSPINE, please e-mail pressrelease@linkspine.com or visit www.linkspine.com.
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