Integrity Life Sciences has announced the addition of another US Food and Drug Administration (FDA) clearance for a new medical device for the treatment of spine and disc related conditions.
Integrity Life Sciences submitted the application for an additional 510 (k) clearance in response to market demand. The new device will be added to the other products that Integrity sells.
Integrity’s initial FDA clearance was issued for the 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 newest version of the ISCS will directly and exclusively target the low back region, or lumbar spine.
Integrity Life Sciences sales and marketing vice president Gary Dixon noted 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. 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," Dixon added.
Integrity Life Sciences delivers a multitude of orthotic treatment options to address one of the most costly systemic ailments in the world, chronic low back and neck pain. The advanced solution begins with the Integrity Spinal Care System. Integrity’s medical devices are non-surgical spinal decompression therapy systems engineered to provide pain relief for compressive and degenerative conditions of the spine.
Specifically, conditions that may be treated include: neck pain 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.
Additionally, Integrity offers the very effective Integrity gel support brace. The Integrity gel support brace is a lumbar support brace that is a fitting compliment to non-surgical spinal decompression. The Integrity Gel Support Brace was designed as an adjunct therapy for those suffering from back pain and with the back pain sufferer’s needs in mind. The Integrity gel support brace can be used with or without Integrity’s non-surgical spinal decompression medical devices, and is an excellent treatment option for personal home use.