NLT SPINE, a manufacturer of minimally invasive spine surgery products, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its generation 2.0 PROW FUSION and eSPIN lumbar interbody fusion products, which are intended for spinal fusion procedures.
Based on the company’s non-linear core technology, the new PROW FUSION interbody fusion device and delivery system are indicated for spinal transforaminal lumbar interbody fusion procedures.
NLT SPINE’s non-linear core technology allows the insertion of large implants and instruments through a small incision.
The previous version of the PROW FUSION device has been already approved by the FDA.
The new enhanced design PROW FUSION device 2.0 has new material and fewer instruments required to perform the procedure.
eSPIN can be used in cutting and grinding intervertebral disc material during discectomy for fusion procedures.
FDA has already approved the previous version of eSPIN.
The generation 2.0 enhancements for the eSPIN included an optimized cutting tips design and additional irrigation capability.
NLT SPINE CEO Didier Toubia noted the FDA clearance for two of the company’s products strengthens its drive and commitment to continue and innovate to offer surgeons and patients a differentiated experience in less invasive spine procedures.
"Alongside a strong intellectual property and FDA clearance for these two leading products, our platform becomes a solid offering in this market. With additional products in our pipeline, we plan to quickly address most of the major segments of the spinal implants business, a $7.6B opportunity worldwide," Toubia added.
PROW FUSION and eSPIN are already in clinical use in Europe.