LinkSPINE is celebrating a couple of “firsts” at this year’s North American Spine Society annual meeting held in Chicago, Ill., (Oct. 14-17). The Rockaway, N.J.-based company, which is focused on minimally invasive implants and techniques for spinal surgery, reported the first U.S. implantation of its FacetLink Mini as well as the first U.S. procedure with the FacetLink Hemi.

The Mini uses two screws and an expandable cross-connector assembly to stabilize the lumbar spine following a tissue-sparing midline decompression procedure. 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.

Dhruv Pateder, M.D., an orthopedic spinal surgeon, performed the first Mini case 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 FacetLink Mini device is quickly and efficiently placed utilizing a very intuitive surgical technique. The patient is doing great and was discharged the next day.”

FacetLink Mini is manufactured from titanium and is designed for placement in the setting of a bilateral decompression through bilateral laminotomies. According to the company, 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.

“FacetLink Mini fits within the bounds of a midline decompression exposure, requiring no additional dissection beyond what was planned for the decompression itself,” said Massimo Calafiore, president of LinkSPINE. “This is based upon the medial to lateral screw trajectories that 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 LinkSPINE, predicted positive results in the United States based on the company’s early clinical experience in the European Union, which he characterized as “very encouraging,” with 80 cases performed in the past 30 months

Faheem Sandhu, M.D., professor of neurosurgery and director of spine surgery at Medstar Georgetown Hospital in Washington, D.C., performed the first U.S. 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,” said 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.”

“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,” said Calafiore. “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.”

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 FacetLink 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; and/or degeneration of the facets with instability.

According to company officials, additional products are under development that 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,” said Farrell.

To learn more about the Hemi and Mini, click on the video below:

Facetlink Mini & Hemi – HD from Ghost Productions on Vimeo.