SpineEX lateral lumbar device for disc diseaseDecember 13, 2018
SpineEX, Inc, a medical device company has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Sagittae lateral lumbar interbody fusion (LLIF) device.
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.
This personalized, expandable device is designed to minimize impaction, maximize indirect decompression, and provide a large graft space optimal for lumbar fusion procedures. It provides up to 8mm of continuous in situ expansion, with up to 30° of continuous in situ lordotic adjustment.
Available in five sizes,Sagittae provides several options for surgeons to address optimal sagittal balance, while minimizing burdensome implant inventory traditionally required for each procedure.
LLIF devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment, the company said.