Inspan LLC has announced that it has received US Food and Drug Administration (FDA) clearance for its interspinous plate fixation device to be used for spinal fusion and spinal stenosis from T1-S1.
The Inspan Spinous Process Plate System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine. It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for spondylolisthesis, trauma, tumour, or degenerative disc disease. The device is intended for use with bone graft material and is not intended for standalone use.
Kingsley Chin, a board-certified orthopaedic spine surgeon and the inventor of Inspan, said: “We are grateful for this decision by the FDA and we are happy for all the patients that we can now treat who have spinal stenosis with degenerative discs and facets who can expect long term relief.
“Inspan will fixate and stabilise the facets and discs at the same time that it distracts and decompresses the spinal canal, lateral recess and foramen to relieve nerve compression from stenosis.”
In addition, a recent publication in the Journal of Spine Surgery demonstrated the Inspan device’s efficacy at greater than five-year follow-up when used to treat spinal stenosis at L4-L5. Inspan is currently awaiting publication of its greater than five-year follow-up L5-S1 data on spinal stenosis treatment.
“We felt confident that Inspan’s long track record of success for spinal stenosis and fusion were strong, but we never imagined such a quick and decisive decision by the FDA to allow indication for use to treat spinal stenosis,” said John Sullivan, vice president of regulatory and quality at KICVentures Group, Inspan’s parent company.
William Costigan, a board-certified orthopaedic spine surgeon at Congress Orthopaedic Associates (Pasadena, USA), commented: “I have used other interspinous devices but Inspan is the only one I now use frequently with excellent results in either a hospital or outpatient ambulatory surgery centre.”
“Inspan has given me great confidence I can treat a lot of my patients successfully as a pain physician who performs outpatient interventional spine surgery,” added Michael Esposito, a board-certified anaesthesia pain management physician at Florida Pain Institute (Melbourne, USA).