The US Food and Drug Administration has given 510(k) clearance to NLT Spine for its eSPIN discectomy system.
The already CE-marked 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 who 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 (i.e. posterior pedicle screw and rod systems).
eSPIN addresses several challenges associated with manual disc preparation instruments. According to NLT Spine, eSPIN demonstrated the following benefits:
- Significant disc evacuation in the contra-lateral side of the disc
- 67% more disc volume removed compared to standard instruments
- 83% fewer instrument passes by the exiting nerve
The eSPIN system consists of a set of single use cutting tips, a hand-held instrument, a motor adaptor and a set of access and positioning instruments.