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NLT SPINE reports positive clinical results for new lumbar interbody fusion device

NLT SPINE : 02 July, 2012  (Company News)
Initial results from clinical experience with NLT SPINE's PROW FUSION device are being reported as highly positive says the company.
NLT SPINE's PROW FUSION, a 510(k)-cleared device and delivery system, is intended for spinal fusion in transforaminal (TLIF) procedures. The system is based on NLT SPINE's non-linear core technology, which allows for inserting large implants and instruments through a small incision.

"I have been pleased with the use of this innovative device in surgery and the clinical results thus far," reported Dr Paul McAfee, Director of the Scoliosis and Spine Center of Maryland and a nationally recognized expert in spine surgery, who has performed procedures using the PROW FUSION at St Joseph Medical Center in Baltimore. "Thanks to the unique capabilities of PROW FUSION, it is well positioned to change the way MIS interbody fusion surgery is performed."

In recent months, clinical use of the device has begun through a limited product release in the US and under clinical study in Europe. Surgery was performed in patients who suffer from symptomatic Degenerative Disc Disease with up to Grade I spondylolisthesis. Prior to surgery, all patients underwent a regimen of at least six months of non-operative treatment without resolution of symptoms.

Results thus far were successful in terms of increased quality of life, stability achieved by PROW FUSION and safety of the procedure. The improved stability after PROW FUSION implant insertion enabled a successful disc height correction.

Commenting on the device's benefits to patients, Dr McAfee added: "The implant is uniquely designed to be delivered through a small incision, but is then deployed to provide a large footprint within the disc. It also provides for a substantial bone graft surface area for the interbody fusion. These factors may lead to improvements in both the biomechanical stability and the fusion rate."

"We have received positive feedback on the use of PROW FUSION and the results of the early clinical experiences have been very good," said Didier Toubia, Chief Executive Officer of NLT SPINE. "As we prepare for the extended launch of the PROW FUSION system in early 2013, we are pleased to see it live up to its technological promise to improve patient care."
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