NLT Spine Receives Clearance for Discectomy System

NLT Spine has received 510(k) clearance from the U.S. Food and Drug Administration for its Espin (styled “eSPIN”) powered discectomy system. A discectomy is the surgical removal of herniated disc material that presses on a nerve root or the spinal cord. Espin is the cutting technology used in the system.

Espin is used to cut and grind intervertebral disc material during discectomy for fusion procedures in L2-S1 (a designation of the region in the spinal cord that controls the leg and foot regions of the body) spinal segments in patients with degenerative disc disease (DDD). These patients also may have up to Grade I spondylolisthesis (where a vertebra in the lower spine slips out of position) or retrolisthesis (posterior displacement of one vertebral body less severe than a dislocation) at the affected levels. The device, together with Prow Fusion, is used with federally-cleared supplemental spinal fixation systems for the lumbosacral spine (i.e. posterior pedicle screw and rod systems).

The system has received the CE Mark and already has been marketed in Europe.

“Espin is well suited for minimally invasive spine surgery offering a predefined, consistent and repeatable procedure,” said Didier Toubia, CEO of NLT Spine. “Together with the Prow Fusion lumbar interbody fusion system, NLT Spine offers a complete procedural solution.”

According to NLT Spine officials, Espin addresses several challenges associated with manual disc preparation instruments. The company claims it has demonstrated the following capabilities of Espin: Significant disc evacuation in the contra-lateral side of the disc; 67 percent more disc volume removed compared to standard instruments; and 83 percent fewer instrument passes by the exiting nerve.

Based in Israel with U.S. offices in Dedham, Mass., NLT Spine specializes in the development of minimally invasive spinal surgery and percutaneous procedures for treating degenerative spinal conditions.

Image of Espin discectomy tool courtesy of NLT Spine.