Inspan’s Interspinous Plate Fixation Device Receives FDA Clearance

Inspan has been FDA cleared since 2010 and thousands have been implanted safely with excellent clinical outcomes with no reported spinous process fractures or adverse device related events. A recent publication on Inspan in the spine journal being used to treat spinal stenosis at L4-5 with greater than five-year follow-up demonstrates the proof for its effectiveness but this new recognition by the FDA to allow for treatment of spinal stenosis as an official indication for use means Inspan can be marketed for spinal stenosis.
 
Inspan is awaiting publication of its greater than five-year follow-up L5-S1 data on spinal stenosis treatment. Interventional pain management, radiologists and physiatrists who were limited to use Vertiflex for spinal stenosis can now use Inspan for the same patients indicated for Vertiflex but also for many more patients who have spinal stenosis from T1 to S1. Many of the patients who have degenerative spine disease have spinal stenosis and so Inspan has a broad population of patients that would qualify for spinal fusion and surgery for spinal stenosis.
 
“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 stabilize 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,” said Dr Kingsley R Chin, professor and board-certified orthopedic spine surgeon and inventor of Inspan.
 
“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, VP of Regulatory and Quality for KICventures.
 
“Had we failed we would still have pursued indication for use to treat spinal stenosis as we see the market need for Inspan being a superior device, so we are ecstatic to have avoided the five years to complete a FDA clinical study at a cost of over $50 million,” said Aditya Humad, CFO of KICventures.
 
“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 center,” said board-certified Orthopedic Spine surgeon William Costigan MD, MBA.
 
“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,” said Dr Michael Esposito a leading board-certified anesthesia pain management physician.