The US Food and Drug Administration (FDA) has granted 510(k) approval to NLT SPINE's new eSPIN spinal system, designed for use with Prow Fusion for treating degenerative disc diseases.
The approval was based on the eSPIN device’s efficacy of providing 67% more disc volume removed compared to standard instruments.
The eSPIN system, which comprises of a set of single use cutting tips, a hand-held instrument, a motor adaptor and a set of access and positioning instruments, is designed for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments.
The CE-marked eSPIN device together with Prow Fusion are used along with supplemental spinal fixation systems for use in the lumbosacral spine.
NLT SPINE CEO Didier Toubia said eSPIN is well suited for minimally invasive spine surgery offering a predefined, consistent and repeatable procedure.
"Together with the PROW FUSION lumbar interbody fusion system, NLT SPINE offers a complete procedural solution," Toubia added.
"We are very pleased to announce that yet another NLT SPINE product has been cleared by the FDA, and our aim is to continue to develop innovative capabilities and technology that address complete procedural solutions for minimally invasive spine surgery."