FDA clears lumbar interbody fusion device from Zavation Medical

Zavation Medical announced today that it received FDA 510(k) clearance for its eZspand lateral expandable lumbar interbody fusion device.

Flowood, Mississippi-based Zavation designed the eZspand lateral, part of the Zavation eZspand interbody system, with precision and continual expansion to offer an optimized fit for each patient, allowing for the enhancement of structural stability and improved sagittal balance.

The company said in a news release that the Zavation eZspand lateral does not require secondary locking, minimizing procedural steps. Its cage has up to 15° lordosis and the ability to back fill with bone graft and each implant expands to 6mm from the insertion height to create a large graft window that facilitates fusion.

Zavation boasts that continuous height adjustment up to 6mm and no secondary locking step separates the eZspand lateral from competitors.

The spinal implant has indication for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients, intended for use at either one level or two contiguous levels in the lumbar spine from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. The device is intended for patients who have had six months of non-operative treatment.

Zavation eZspand interbody system implants are meant to be used with supplemental internal fixation appropriate for the implanted level.

“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,” CEO Jeffrey Johnson said in the release. “With restoration of alignment being of critical importance, the eZspand lateral was developed to help surgeons address stability and sagittal alignment, while maximizing 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.” MassDevice