NLT Spine, a developer of minimally invasive spine surgical devices, has reported positive results from the clinical trial of its Prow Fusion lumbar interbody fusion delivery device.
Based on the non-linear core technology, the Prow Fusion device is designed for use during spinal fusion in transforaminal procedures.
Patients suffering from symptomatic degenerative disc disease with up to Grade I spondylolisthesis were included in the surgery.
Prior to surgery, all patients underwent a regimen of at least six months of non-operative treatment without resolution of symptoms.
The results showed an increase in patients’ quality of life and in safety of procedure, as well as improved stability of disc height correction after insertion of Prow Fusion implant.
Maryland Scoliosis and Spine Center director, Paul McAfee, said the implant is 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," McAfee added.
"These factors may lead to improvements in both the biomechanical stability and the fusion rate."
Clinical use of the FDA 510(k)-cleared device in recent months has begun through a limited product release in the US and the device is under clinical study in Europe.
NLT Spine CEO, Didier Toubia, said the company has received positive feedback on the use of the Prow Fusion and the results of the early clinical experiences have been good.
"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," Toubia added.
