FDA clears lumbar interbody fusion device from Zavation Medical

Zavation Health-related announced nowadays that it gained Food and drug administration 510(k) clearance for its eZspand lateral expandable lumbar interbody fusion unit.

Flowood, Mississippi-based Zavation intended the eZspand lateral, portion of the Zavation eZspand interbody program, with precision and continual growth to present an optimized fit for every single affected individual, making it possible for for the improvement of structural security and improved sagittal balance.

The company mentioned in a information release that the Zavation eZspand lateral does not need secondary locking, minimizing procedural techniques. Its cage has up to 15° lordosis and the capacity to again fill with bone graft and each implant expands to 6mm from the insertion top to build a large graft window that facilitates fusion.

Zavation features that continuous peak adjustment up to 6mm and no secondary locking action separates the eZspand lateral from rivals.

The spinal implant has indication for spinal fusion strategies to be utilized with autogenous bone graft in skeletally mature sufferers, meant for use at possibly a person degree or two contiguous levels in the lumbar spine from L2 to S1 for the treatment method of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. The gadget is supposed for individuals who have experienced 6 months of non-operative treatment.

Zavation eZspand interbody procedure implants are meant to be employed with supplemental internal fixation proper for the implanted level.

“Our merchandise progress team’s devotion to creatively blending simplicity and precision in a robust products design has developed an expandable products that we believe is the new gold common in facilitating patient fusion in a seamless and simplified treatment,” CEO Jeffrey Johnson mentioned in the release. “With restoration of alignment staying of important value, the eZspand lateral was formulated to aid surgeons handle stability and sagittal alignment, although maximizing lordotic correction. This product or service is an example of Zavation’s motivation to giving modern and differentiated products in conjunction with current market-main buyer support to ideal serve our surgeons and distributor community.”