Israeli Company wins 510(k) clearance for TLIF Fusion Device
Award Winning Israeli Spine Company Gets 510(k) Clearance (Bilione Young @ OTW)
NLT SPINE, an Israeli developer of minimally invasive spine surgery (MISS) products, has just received FDA 510(k) clearance for its PROW FUSION device. NLT SPINE is a winner of the 2011 Spine Technologies Award, given byOrthopedics This Week during the North American Spine Society conference in November 2011. The judges recognized companies that presented the most innovative and promising products in 2011 to treat back pain.
Invented by Dr. Tzony Siegal, the PROW FUSION device and delivery system are intended to be used for spinal fusion in transforaminal-lumbar interbody fusion TLIF) procedures. The technology allows the surgeon to insert large implants and instruments through a small incision.
Among the attributes of the PROW FUSION, according to the February 1 press release, is a footprint that is larger than existing TLIF devices, which provides 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.
Company officials note that the implant also has a large capacity for bone graft material, greater than in more traditional TLIF devices, which allows for greater bone graft-to-endplate contact surface area, potentially improving fusion rates.
The non-linear design fits well with NLT SPINE’s mission to deliver complete MISS procedures, including disc space preparation, deployment, and supplemental fixation and implant delivery, as required. The company expects PROW FUSION to provide benefits to patients 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.
“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. “We view our technology platform as a significant advancement in minimally invasive spine procedures….”