NLT SPINE Receives 510(k) Clearance for Its Lumbar Interbody Fusion Device, PROW FUSION(TM)

KFAR SABA, Israel, Feb 01, 2012 (BUSINESS WIRE) — NLT SPINE, a developer of Minimally Invasive Spine Surgery (MISS) products, today announced that its PROW FUSION(TM) device received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
NLT SPINE’s PROW FUSION(TM) Transforaminal-Lumbar Interbody Fusion (TLIF) device and delivery system are intended for spinal fusion in TLIF procedures. The product was developed based on NLT SPINE’s non-linear core technology which allows for inserting large implants and instruments through a small incision. NLT SPINE’s non-linear core technology was invented by Dr. Tzony Siegal.
Some of the attributes of the PROW FUSION(TM) include a footprint that is larger than existing TLIF devices, with the goal of providing greater biomechanical stability and less subsidence postoperatively. Due to the non-linear design, which allows for deployment of the implant within the intervertebral disc space, the implant can be delivered through a small incision with minimal disruption to muscles and surrounding tissues. The implant also has a significant volume for bone graft material, larger than traditional TLIF devices, allowing for greater bone graft-to-endplate contact surface area, potentially improving fusion rates.
The non-linear design is well suited to MISS and fits well with NLT SPINE’s mission to deliver complete MISS procedures, including disc space preparation, implant delivery / deployment and supplemental fixation delivery, as required. The company expects PROW FUSION(TM) to offer benefits to the patients treated as well as to surgeons and hospitals. For surgeons and hospitals, it is expected to offer efficient and user-friendly MISS procedures, while for patients it is expected to minimize recovery time.
PROW FUSION(TM) was recently granted the ‘2011 Spine Technologies Award’ for Minimally Invasive Spine Care by the renowned Orthopedics This Week publication. The award was handed to NLT SPINE during the North American Spine Society conference (NASS) in Chicago in November 2011, and according to Orthopedics This Week, the surgeon judges selected companies that presented the most innovative and promising products in 2011 to treat back pain. “We conclude 2011 with significant achievements for the company on its path to improving the care delivered to patients suffering from spine conditions,” said Didier Toubia, CEO, NLT SPINE. “We view our technology platform as a significant advancement in minimally invasive spine procedures and the PROW FUSION(TM)solution is only the first step for NLT SPINE.”