Globus Medical (Audubon, Pennsylvania), which bills itself as the largest privately held spinal implant manufacturer in the world, has launched the Gateway Thoracolumbar System, designed for the treatment of thoracolumbar spine instability, or lower thoracic or lumbar spine instability.

According to the company, such instability can exist due to fracture; tumor; degenerative disc disease; scoliosis, which results in curvature of the spine; kyphosis, which can result in a hump back; lordosis, or "sway back"; spinal stenosis or a failed previous spinal surgery.

The Gateway System works with the company's Revere System, which relies on screws and non-threaded locking caps to support the spine. It works in conjunction with the company's XPand spacer, which it says is the only expandable corpectomy spacer on the market. A corpectomy involves either total or partial removal of the vertebral body.

Larry Binder, group engineering manager for Globus, told Medical Device Daily that the company's "half-a-plate and half-a-rod construct" is very different from what other solutions offer.

"The idea behind what a lot of people were doing for lateral type fixation is they were using staples and then putting two types of pedicle screws into a staple into a vertebral body from the lateral perspective," he said. He said that typically one was done from the superior and one from the inferior vertebral body, with the four screws connected with rods.

Other times, he said, surgeons would use a pedicle screw approach, but only use a single rod from one screw to the next that is, connecting one vertebral body to the next with a single rod.

"The problem with that kind of construct is it's not as stable as a dual-rod construct where you would have . . . two screws in the vertebral body," he said. "What we wanted to do was combine the best of both kinds of systems . . ."

Hence, the half-plate, half-rod construct.

Globus said that among its features, Gateway, which is essentially a plate that fits in with the other components of the Globus thoracolumbar system, ensures total access to all of the anatomic structures involved in the treatment before, during and after insertion. That is one of the main design goals for the device system.

"I think one of the big things about [this system] is it gives the surgeon the ability to do the procedures in the order . . .they're comfortable with," Binder told MDD, noting that some systems "require the surgeon to do certain steps before others," whether that's putting in screws first, putting in staples first or doing the corpectomy first.

Binder said that with most dual-rod systems, surgeons are required to insert a plate first.

"With [our system] you can really do it after or partially through your procedure, which is great, because it allows them to" have access even after the corpectomy, or access it even as they're completing the procedure, Binder said. "They can always go back in and readjust and add more bone, or reposition their expandable cage to get the perfect fit before they finally lock everything in place and close up the patient."

The Gateway System is available now through Globus' select exclusive distributors or through those of the company's direct sales force.

"Gateway provides the benefits of a rigid plating system and the flexibility of single-rod application," said Alexander Vaccaro, MD, professor of neurosurgery and orthopedic surgery at Thomas Jefferson University Hospital (Philadelphia) and co-director of Reconstructive Spine Service at Jefferson's Rothman Institute. "Visibility of the graft host bone junction is greatly enhanced, and the surgeon is no longer burdened with the technical demands of plate sizing often encountered in anterior thoracolumbar reconstruction."

Globus was founded in 2003 by a group of medical device professionals with the intent to develop and market products designed to enable spine surgeons to utilize both fusion and non-fusion solutions.

It says it has a "full portfolio" of spinal fusion products and "initiatives" in biomaterials development. The company says it is also a leader in the development of "motion-sparing" technology.

Globus reports more than $100 million in annualized revenue.

Globus in late 2005 reported closing on a $10 million credit facility from Silicon Valley Bank (SVB; Santa Clara, California) (MDD, Sept. 19, 2005).

Last year, the company purchased a 133,000-square-foot, mixed-use facility in King of Prussia, Pennsylvania. The site, situated on 13 acres in the Valley Forge Business Center, more than quadrupled the size of Globus's facilities, previously housed in three separate, leased locations.

The facility was purchased to serve as serve as a training facility for spine education, featuring a cadaver lab, dry lab and a multi-media classroom that accommodates up to 40 participants.