MIS spine developer NLT Spine, has seen two of its generation 2.0 products designed for spinal fusion procedures received FDA 510(k) clearance. PROW FUSION™ and eSPIN™ both target the lumbar interbody fusion market, which currently represents an opportunity of approximately $1.3 billion globally.
NLT Spine specializes in the development of innovative spine surgery instrumentation and implants for treating degenerative spinal conditions through small surgical incisions.
PROW FUSION™ Interbody Fusion device and delivery system are intended for spinal transforaminal lumbar interbody fusion procedures (TLIF). 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. The FDA has already cleared the previous version of the device, however generation 2.0 offers enhanced design, new material, and fewer instruments required to perform the procedure.
eSPIN™ is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures. Similarly to PROW FUSION™, the previous version of eSPIN™ has been cleared by the FDA, and generation 2.0 enhancements include an additional irrigation capability, and optimized cutting tips design.
Both products are already in clinical use in Europe.
“The FDA clearance for two of our products strengthens our drive and commitment to continue and innovate to offer surgeons and patients a differentiated experience in less invasive spine procedures,” said Didier Toubia, NLT SPINE’s CEO.
“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.”
Source: NLT Spine