Zavation Medical Products has received 510k clearance from the US Food and Drug Administration (FDA) for its expandable lumbar interbody fusion device, eZspand Lateral.
Part of the Zavation eZspand Interbody System, the eZspand Lateral device offers an optimal fit for individual patients through expandable precision as well as continual expansion.
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By GlobalDataThis provides improved structural stability and sagittal balance.
The company stated that the new lumbar interbody fusion device does not require secondary locking, which reduces the number of steps necessary for procedures.
The eZspand Lateral’s cage has a lordosis of up to 15° and can backfill with bone graft. Each implant can expand up to 6mm from the insertion height, creating a large graft window and enabling fusion.
Zavation Medical noted that the continuous height adjustment, up to 6mm expansion and no secondary locking step distinguishes the eZspand Lateral from its competitors.
Zavation Medical CEO Jeffrey Johnson said: “Our product development team’s dedication to creatively blending simplicity and precision in a robust product design has produced an expandable product that we believe is the new gold standard in facilitating patient fusion in a seamless and simplified procedure.
“With restoration of alignment being of critical importance, the eZspand Lateral was developed to help surgeons address stability and sagittal alignment while maximising lordotic correction.
“This product is an example of Zavation’s commitment to offering innovative and differentiated products in conjunction with market-leading customer service to best serve our surgeons and distributor network.”
The company noted that implants in the Zavation eZspand Interbody System are developed for use with autogenous bone grafts in skeletally mature patients during spinal fusion procedures.
They are intended for use at either one level or two contiguous levels, from L2 to S1, in the lumbar spine to treat degenerative disc disease (DDD) with up to Grade I spondylolisthesis.
Zavation Medical stated that patients who have completed six months of non-operative treatment will be eligible for treatment using the device.
