Recon

Globus Medical Announces CREO MIS(TM), a Low Profile Minimally Invasive Posterior Stabilization System

AUDUBON, Pa., Oct. 22, 2015 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, announced the introduction of the CREO MIS Pedicle Screw System.

CREO MIS is a thoracolumbar posterior stabilization system featuring extended modular screw heads. The screw heads are one of the smallest diameters available on the market which helps to minimize muscle disruption and to reduce clutter at difficult levels such as L5-S1. The extremely low profile design of CREO MIS continues to provide the strength and rigidity of a traditional percutaneous reduction system allowing for manipulation and deformity correction. With reduction options up to 30mm and the ability to assemble the extended screw heads to a wide range of screw offerings, CREO MIS is a comprehensive and customizable solution for all cases.

“Globus continues to lead the way with a growing portfolio of MIS related products, including this important addition to our CREO® Pedicle Screw System platform. Surgeons appreciate the intuitive simplicity of the CREO MIS platform including the ability to insert the locking cap through the screw head in a controlled, guided manner where the rod is then captured, reduced and locked in one simplified step,” commented Andrew Iott, Senior Vice President of Product Development. “CREO MIS has been used in over 300 spine procedures since its launch in the second quarter of 2015, and the feedback from surgeons has been extremely positive. We are proud to add yet another innovative solution to our suite of MIS products. This product is designed to help surgeons treat their patients with less tissue disruption leading to faster recovery times. We will continue to provide innovative solutions that allow our surgeons to better improve the lives of their patients.”

Indications

The CREO® Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients (CREO® 4.75 only). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO® Stabilization System is intended to be used with autograft and/or allograft.

In addition, the CREO® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO® 4.75 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CREO® 4.75 Stabilization System is intended to be used with Autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

In order to achieve additional levels of fixation in skeletally mature patients, the CREO® Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod), REVERE® 4.5 Stabilization System (4.5mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. In order to achieve additional levels of fixation in pediatric patients, the CREO® Stabilization System rods may be connected to the REVERE® 4.5 Stabilization System using corresponding connectors. Refer to the REVERE®, REVERE® 4.5, or ELLIPSE® system package insert for instructions and indications of use.

About Globus Medical, Inc.

Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.

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