Camber Spine has initiated the full US launch of its SPIRA-P posterior lumbar spacer and SPIRA-T oblique posterior lumbar spacer devices.
News of launch comes on the heels of Camber’s announcement last month that it has received US Food and Drug Administration (FDA) 510(k) clearance for both products, which are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1.
Part of the SPIRA product platform, the SPIRA-P posterior lumbar spacer can be utilised to accommodate posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) procedures and features a patented open architecture design for optimal endplate load distribution. In addition, says Camber Spine, its uniquely designed surface allows for cell adhesion and bone cell proliferation while its interconnected porosity design mimics bone, say Camber Spine.
The SPIRA-T oblique posterior lumbar spacer features the same qualities, but is designed specifically to accommodate traditional or ‘insert and rotate’ TLIF procedures. Its shape is angled for a 25° oblique insertion technique to optimise lordosis, according to the company.
The SPIRA products are designed to decrease the risk of subsidence with optimised endplate distribution and provide good visibility for fusion. The devices’ bone-like surface design intends to promote ‘mechanical fusion’ bone ingrowth for short term stability and optimised biomimetic scaffolding designed to encourage osteogenesis.
Daniel Pontecorvo, co-founder and CEO of Camber Spine, said: “We are very excited to deliver more innovation-based solutions and options to the surgical community with our national launch of SPIRA-P and SPIRA-T, the first SPIRA implants available for the TLIF market.
“Providing structural stability following discectomy, the SPIRA posterior lumbar spacers have different shapes and designs to accommodate a broader array of posterior and transforaminal approaches and techniques.”