NLT SPINE, a developer of minimally invasive spine procedures, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Prow Fusion and eSPIN, designed for spinal fusion treatments.
Prow Fusion interbody fusion device and delivery system are intended to be used for spinal fusion in transforaminal-lumbar interbody fusion (TLIF) procedures.
Its non-linear design allows 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 FDA has already cleared the previous version of Prow Fusion; however, the second generation offers enhanced design, new material, and fewer instruments required to perform the procedure.
eSPIN is used to cut and grind intervertebral disc material during discectomy for fusion procedures.
Similarly to Prow Fusion, the first generation of eSPIN has been cleared by the FDA. It has also received the CE Mark and is already being marketed in Europe.
The second generation of eSPIN comes with an additional irrigation capability and optimised cutting tips design.
NLT SPINE CEO Didier Toubia said the FDA clearance for two of company’s products strengthens its commitment to continue offering surgeons and patients 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,” Toubia said.
“With additional products in our pipeline, we plan to quickly address most of the major segments of the spinal implants business, a $7.6bn opportunity worldwide.”
According to the company, Prow Fusion and eSPIN devices, which are already in clinical use in Europe, target the lumbar interbody fusion market that currently represents an opportunity of approximately $1.3bn globally.
Accelmed chairman and the main investor in NLT SPINE Dr Uri Geiger said: “Combining this kind of breakthrough platform based on Israeli Innovation with a strategic partner with a solid US commercial infrastructure is now a viable option, and Accelmed will support such an initiative.”
According to GlobalData estimates, the spinal fusion market in the US was valued at $3.95bn in 2012 and is expected to grow at a CAGR of 1.9% to reach $4.5bn by 2019.