NLT SPINE Receives CE Mark for its eSpin(TM) Device and Performs First Clinical Cases in Europe

KFAR SABA, Israel, Apr 19, 2012 (BUSINESS WIRE) — NLT SPINE, a developer of products aimed for Minimally Invasive Spine Surgery (MISS) and percutaneous procedures, announced today that its eSpin discectomy device has received CE Mark approval, enabling the company to market it in Europe.eSpin can be used as part of a lumbar interbody fusion procedure, equipping surgeons with a high performance instrument for spinal discectomy. The powered tool evacuates the disc nucleus and can be used to prepare the disc space before placing interbody fusion implants.The company has recently started using the approved eSpin for discectomy in Europe, and in the future eSpin(TM) will be integrated into NLT SPINE’s PROW LIF(TM) (lumbar interbody fusion) procedures.
“eSpin is only one product of our offering. Our aim is to equip surgeons with a set of products and instruments that are needed to perform complete MISS procedures.” said Didier Toubia, CEO, NLT SPINE.
“Receiving the CE Mark for eSpin demonstrates our commitment to the highest standards of quality and functional design, aligned with the strict guidelines of the European regulations for medical devices,” he added.
A 510(k) notice for the eSPIN is currently under review by the FDA and the device is not currently for sale in the US.