NLT SPINE: 510(k) Clearance for eSPIN (Orthopedics This Week)
NLT SPINE is celebrating the announcement that its eSPIN powered discectomy system has received 510(k) clearance from the FDA. eSPIN is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. The device, together with PROW FUSION, is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The company indicates that eSPIN has shown significant disc evacuation in the contra-lateral side of the disc, 67% more disc volume removed compared to standard instruments, and 83% fewer instrument passes by the exiting nerve.
Asked about the development process, Didier Toubia, CEO of NLT SPINE told OTW,
There are many interesting challenges that were faced along the development process of the eSPIN device. Many scientific publications emphasize the importance of a proper disc preparation for fusion procedures and today’s tools an...
