Spira-C cervical interbody cleared by US FDA

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Camber Spine Spira-CCamber Spine has announced the clearance by the US Food and Drug Administration (FDA) of its Spira-C Open Matrix cervical interbody device, a fusion implant that utilises the company’s Surface By Design surface enhancement technology. Spira-C is Camber Spine’s second implant in the Spira line to be approved for the US market.

Spira-C features an arched design made by additive manufacturing that “creates an optimal environment for cell proliferation and bone growth,” the USA-based company says. Its proprietary Surface by Design technology is a roughened titanium designed to facilitate bone growth through an optimised pore diameter. The previously-approved Spira Open Matrix also features Surface By Design and a similar titanium “open architecture” design.

The roughed titanium surface adds “significant friction”, says Daniel Pontecorvo, CEO of Camber Spine, which also contributes to the fusion capabilities of the interbody device.

“The engineers and designing surgeons leveraged the latest in 3-D printing technology to incorporate the needs at each step of the fusion process with the SPIRA™ family,” comments Pontecorvo.

“Lastly, long-term stability is achieved with the ultimate endplate-to-endplate fusion. The newly forming bone follows the multiple arches incorporated with the Surface By Design to encourage ongrowth and ingrowth throughout the cage,” he adds.

The arched design of the Spira-C enables the device to effectively distribute stress forces, which also enhances fusion, according to Pontecorvo.

Spira-C, notes a press release from Camber Spine, is currently indicated for use at up to two contiguous levels in patients who have undertaken at least six weeks of conservative treatment for radiographically-confirmed degenerative disc disease (DDD) with up to grade 1 spondylolisthesis, at one or two levels from C3–C7.

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