Inspan Gains FDA 510(k) Clearance for Interspinous Plate

By Julie A. Vetalice

Inspan Gains FDA 510(k) Clearance for Interspinous Plate

KICventures Group, parent company of Inspan, received FDA 510(k) clearance to market the Inspan interspinous plate fixation to be used for spinal fusion and spinal stenosis. Patients can now be treated with Inspan for spinal fusion without pedicle screws or for spinal stenosis without the need for laminectomy to remove the spinous processes and lamina.

Inspan has been FDA-cleared since 2010. This new recognition by FDA to allow for treatment of spinal stenosis as an official indication for use means that Inspan can be marketed for spinal stenosis. 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 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.

Source: Inspan

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory