The eZspand Lateral Cage is an addition to the firm’s eZspand Interbody System with more precision and continual expansion for an optimised fit for each patient
eZspand Lateral Cage by Zavation Medical. (Credit: PR Newswire/Zavation Medical Products, LLC.)
Zavation Medical has received the US Food and Drug Administration (FDA) 510(k) clearance for its expandable lumbar interbody fusion device, eZspand Lateral.
The Zavation eZspand Lateral, which forms part of the eZspand Interbody System, has expandable precision and continuous expansion to offer an optimal fit for each patient.
According to the firm, the customised fit enables improved structural stability and sagittal balance.
The device does not require secondary locking, reducing the number of steps in the process.
Zavation eZspand lateral’s cage has a lordosis of up to 15 degrees and can be backfilled with bone graft.
Each implant expands to 6mm from its insertion height, allowing for a large graft window and easier fusing.
Zavation Medical claims that the presence of continuous height adjustment, up to 6mm expansion, and no secondary locking step distinguish the eZspand Lateral from its rivals.
The latest implant is intended for use in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis in spinal fusion procedures with autogenous bone graft.
It is intended for use at either one level or two contiguous levels in the lumbar spine from L2 to S1 for the treatment of DDD with up to Grade I spondylolisthesis.
The company said that the patients who have completed six months of non-operative treatment are eligible for the device.
Zavation Medical chief executive officer 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 the 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.”