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Invention Gives Spinal Surgeons a New Option

SPINAL ELEMENTS INC.

CEO: Todd Andres.

Revenue: Not disclosed.

No. of local employees: 34.

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Investors: Privately funded.

Headquarters: Carlsbad.

Year founded: 2003.

Company description: A spine technology company for spinal surgeons who demand innovative surgical solutions.

Key factors for success: Spinal Elements has built a reputation for being trustworthy, innovative and different and for consistently having innovative solutions for the market’s needs.

Spinal Elements Inc., a Carlsbad-based spine technology company, has passed an important milestone: doctors have begun to conduct surgeries with the company’s new minimally invasive surgery lumbar system.

Jason Blain, president and co-founder of Spinal Elements, said about five surgeries have been done with the MIS lumbar system by surgeons in Youngstown, Ohio, who are providing input for the system while it’s in development.

“So far, everything’s been going well,” Blain said. “It’s still in a phase where we’re following each procedure and being careful about patient selection as we learn more about the system.”

The MIS lumbar system works in tandem with Spinal Elements’ Mercury Classic spinal system that has been available for use in lumbar spinal fusions since early 2009. The Mercury Classic involves an attachment to the back of the spine that stabilizes the vertebrae while a fusion forms. The new MIS lumbar system comes with a special set of instrumentation that attaches to the implant of the Mercury system and that allows the surgeon to do the procedure through a smaller incision.

“The fact that the Mercury Classic system has been designed to work well as a conventional or MIS system is very beneficial to me,” said spine surgeon Dr. Douglas Musser of Youngstown Orthopaedic Associates. “No matter what my surgical plan, I know that the implant system will be the same.”

Advantages to performing minimally invasive surgeries include less trauma to the patient, less muscle disruption which can lead to shorter hospital stays, and a more rapid return to work or other activity, Blain said.

In general, trends are shifting in favor of minimally invasive surgeries, according to Blain, who says market data shows MIS is growing by 10 percent annually, and about two and a half conventional procedures are performed for every one MIS procedure. Blain added that of the 250,000 lumbar spine procedures performed in the U.S. this year, about 70,000 of them will be minimally invasive procedures.

“We have technologies that will even further expand the desire to do MIS procedures,” he said, explaining that the technologies lend themselves to less disruptive procedures and even smaller incisions. “These products will push the level of disruption to the muscles down even further.”

Blain said during the next 12 months Spinal Elements will start introducing some new technologies that are quite differentiated from what’s available on the market today. About 10 products are planned to be rolled out for use with traditional and MIS procedures.

“We want to help push enabling technology to make more of those procedures minimally invasive procedures,” he said.

A Better Interface

One of Spinal Elements’ recently launched technologies is the Lucent Ti-Bond line of PEEK interbody implants used for spinal fusions. The Ti-Bond’s titanium porous coating, combined with the company’s Lucent PEEK interbody implants, creates the ideal environment for bone healing during fusion, according to Spinal Elements.

Dr. Scott Kitchel, a spinal surgeon at the NeuroSpine Institute in Eugene, Ore., said the interface between the patient’s bone and the implant has traditionally been made of PEEK, or plastic, which doesn’t create a strong bond between the bone and the plastic. When titanium is sprayed on, it creates a more rigid interface than can interdigitate with the bone, he said.

“It helps with stabilizing or holding the implant still and once the implant is stabilized or held still it allows the bone to grow through it and create a solid fusion,” Kitchel said.

Kitchel hasn’t begun using the Ti-Bond as it has only recently been given Food and Drug Administration clearance, but he says he believes it’s an innovative step forward in helping patients.

“It will create some immediate stability for them which may give them a reduction in symptoms or back pain after surgery and create a higher fusion rate,” said Kitchel, who has 25 years of experience as a spinal surgeon.

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