Research & Development
SpineEX wins US FDA's clearance for Sagittae lateral lumbar Interbody fusion device
11 October 2018 -

Medical device company SpineEX, Inc reported on Wednesday the receipt of the US Food and Drug Administration's (FDA) 510(k) clearance for its Sagittae lateral lumbar interbody fusion (LLIF) device for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.

The company stated that DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis.

Sagittae is a personalised, adjustable expandable LLIF device designed to minimise impaction, maximise indirect decompression, and provide a large graft space optimal for lumbar fusion procedures. It is designed for up to 8mm of continuous in situ expansion, with up to 30° of continuous in situ lordotic adjustment. The large single graft chamber can be filled with bone graft material after insertion and adjustment to ensure even contact with both vertebral endplates, added the company.

According to the company, the LLIF procedure uses minimally invasive techniques that approach the spine from the side of the patient, allowing for a larger implant footprint and less disruption to lower back muscles as compared to other approaches, which results in less blood loss and faster recovery.

Available in five sizes, all with independent parallel height or lordotic profiles, Sagittae provides several options for surgeons to address optimal sagittal balance, while minimising burdensome implant inventory traditionally required for each procedure, concluded the company.



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