LinkSPINE Announces First FacetLINK HEMI Implantation

October 21, 2015

Rockaway, NJ – LinkSPINE, a company focused upon simple, less invasive implants and techniques for spinal surgery, announced today the first US implantation of the FacetLINK HEMI. The HEMI device is a low-profile plate that cross connects a Transfacet pedicle screw on the ipsilateral side of a Micro-Decompression to a Translaminar pedicle screw on the contralateral side. It is designed to provide rigid bilateral fixation through a tissue sparing, unilateral decompression approach. 

Faheem Sandhu, MD, Professor of Neurosurgery and Director of Spine Surgery at Medstar Georgetown Hospital, performed the first US HEMI case at Medstar Southern Maryland Hospital in Clinton, MD. “As a neurosurgeon focused on minimally invasive spine surgery, I will often perform a microsurgical decompression through a unilateral approach and use the ‘crossover technique’ to decompress the contralateral recess,” explains Dr. Sandhu. “This approach enables me to address bilateral symptoms through a small exposure and to keep the posterior ligamentous structures completely intact. The HEMI’s ability to secure robust bilateral fixation through this microsurgical decompression is an attractive feature to me. The patient is doing great in the early post-operative period.” 

Massimo Calafiore, President of LinkSPINE states, “The FacetLINK platform is designed to fit within the bounds of a surgeon’s preferred decompression exposure, requiring no additional dissection beyond what was planned for the decompression itself. The HEMI requires only two screws to secure a low profile one level construct versus four screws which are needed when using conventional pedicle screw instrumentation.” 

Dennis Farrell, VP of Marketing and Product Development, adds, “FacetLINK forms the foundation of LinkSPINE’s “Midline Choice” implant platform. Additional products are under development which will integrate with FacetLINK to provide intra-operative flexibility when choosing less invasive stabilization construct based upon patient pathology, anatomy, and surgeon preference. We will continue to focus upon patient outcomes and surgeon feedback to guide our product development efforts.” 

FacetLINK HEMI is manufactured from titanium and is designed for placement in the setting of a bilateral decompression through a unilateral laminotomy.  It is anchored with Trans-articular Pedicle Screws that cross the facets, pin the joints, and terminate at the base of the pedicle. A metal plate 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: 

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. 

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