Integrity Life Sciences has somewhat belatedly announced FDA 510(k) clearance for its Integrity Spinal Care System. In a press release, issued this week, the company says it gained clearance on April 5th, 2011, suggesting it’s been preparing for launch in the interim and is now ready to go.
Integrity Life Sciences claims to deliver an advanced solution to one of the most costly systemic ailments in the world, chronic low back and neck pain. The company’s ISCS 2.0 and Lombare Systems are so-called “non-surgical” spinal decompression therapy systems engineered to provide pain relief for compressive and degenerative conditions of the spine.
Non-surgical spinal decompression is a process whereby forces are applied to the spine in a manner that maximises spinal elongation by relaxing paraspinal muscles, the muscles that guard the spine from injury. In the relaxed state, subsequently applied spinal decompressive forces spread apart the spinal vertebrae relieving pressure on nerves and intervertebral discs.
Where this spinal elongation occurs, pressure drops within the disc which facilitates movement of fluid, carrying nutrients and oxygen inside the disc. Additionally, the reduction in pressure can help draw in herniated disc fluids, reducing the size of the herniation.
The Integrity Spinal Care System provides a program of treatments for relief from pain for those patients suffering with low back pain or neck pain. Each treatment consists of a physician prescribed treatment period on the Integrity Spinal Care System and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include: neck and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
Source: Integrity Lifesciences, PR Newswire