Integrity Life Sciences has announced the U.S. FDA clearance of a new version of its Integrity Spinal Care System (ISCS), a non-surgical medical device that applies therapeutic distraction forces to a patient’s spinal column to alleviate low back and neck pain for a broad range of spinal disorders. The new ISCS will directly and exclusively target the low back region, or lumbar spine.
Integrity Life Sciences delivers a multitude of orthotic treatment options to address chronic low back and neck pain.The company says its medical devices are non-surgical spinal decompression therapy systems engineered to provide pain relief for compressive and degenerative conditions of the spine. Specifically the company’s products are targeted at neck pain and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. The underlying principle is to achieve decompression of intervertebral discs in the form of unloading due to distraction and positioning.
Mr. Gary Dixon, Vice President of Sales and Marketing of Integrity Life Sciences, commented, “The FDA review process for medical devices is very thorough and demanding. Patient safety is of paramount importance with the FDA and gaining an additional market clearance is a major achievement.” Mr. Dixon went on to elaborate about further information soon to be released by Integrity to include a large multi-center clinical outcome study, “With this clearance and the upcoming clinical data soon to be released, we will be able to offer our clinicians additional treatment and educational options with a better approach to dealing with the costly treatment of low back pain.”
Source: Integrity Life Sciences, Inc., PR Newswire