Globus gains FDA OK for spinal disc

Globus Medical got FDA approval for its Secure-C spinal implant--courtesy of Globus Medical

Globus Medical ($GMED) got FDA approval for Secure-C, the company's spinal disc replacement device, saying the tech is demonstrably more successful than current surgeries for disc abnormalities.

The device is an articulating intervertebral disc replacement, and a 380-patient study showed that Secure-C is safer and more effective than the standard-of-care anterior cervical discectomy and fusion surgery, Globus says. Secure-C is implanted to replace diseased or bulging discs, and the device can stabilize the spine while still allowing motion at the operated disc, unlike any other product on the market.

"Secure-C's selectively constrained design allows a natural range of motion, including translation, while preventing dissociation," Globus Vice President Michael Boyer said in a statement.

The approval and launch of Secure-C is Globus' first big step as a publicly traded company. The Audubon, PA, devicemaker pulled in $100 million in its IPO in August, after scaling back expectations from a planned $200 million offering earlier this year.

Founded in 2003, Globus markets more than 100 products to treat spinal disorders, and, the company brought in $331.5 million in sales last year. Globus estimates the world spine market at about $10 billion and says an aging population and growing number of spinal procedures will only push that number northward.

- read Globus' release