KFAR SABA, Israel–(BUSINESS WIRE)–NLT SPINE, a developer
of Minimally Invasive Spine Surgery (MISS) products, today announced that its
PROW FUSION™ device received 510(k) clearance from the U.S. Food and Drug
Administration (FDA).
NLT SPINEs PROW FUSION™
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 SPINEs
non-linear core technology was invented by Dr. Tzony Siegal.
Some of the attributes of the PROW FUSION™ 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 SPINEs mission to deliver complete MISS procedures, including disc
space preparation, implant delivery / deployment and supplemental fixation
delivery, as required.
The company expects PROW FUSION™ 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™ 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™ solution is only the first step for NLT SPINE.”
For more information about the company and technology please
visit http://www.nlt-spine.com
About NLT SPINE
NLT SPINE (formerly NonLinear Technologies) specializes in the development and
marketing of innovative Minimally Invasive Spinal Surgery (MISS) products for
treating degenerative spinal conditions. The companys vision is to improve
patient care and reduce total treatment costs by shifting from traditional open
surgical routines to MISS, employing new methods and technologies to enhance
usability and outcomes.
Led by top international leaders in spinal surgery, NLT
SPINE holds a wide portfolio of pending and issued patents that cover the
non-linear core technology and related implant and instrument technologies.
Posted by Sean Fenske, Editor-in-Chief, MDT
