MIS Spine device company NLT Spine has received 510(k) clearance from the U.S. FDA for its eSPIN powered discectomy system.
NLT Spine specialises in the development of innovative Minimally Invasive Spinal Surgery (MISS) and percutaneous procedures for treating degenerative spinal conditions. In common with many other device entities the company says its vision is to improve patient care and reduce total treatment costs by shifting from traditional open surgical routines to MISS, employing new methods and technologies to enhance usability and outcomes.
The newly cleared 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 pedicle screw and rod fixation systems that have been cleared for use in the lumbosacral spine.
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.
NLT Spine says eSPIN addresses several challenges associated with manual disc preparation instruments and features incllude 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.
“eSPIN is well suited for minimally invasive spine surgery offering a predefined, consistent and repeatable procedure,” said Didier Toubia, CEO, NLT Spine. “Together with the PROW FUSION lumbar interbody fusion system, NLT Spine offers a complete procedural solution. 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.”
The system bears CE Mark and according to NLT Spine has been successfully used in Europe.
Source: NLT Spine, Business Wire