Integrity Life Sciences announces additional US FDA medical device clearance

February 27, 2014 — Integrity Life Sciences recently announced the addition of another U.S. 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 help 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.

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.”

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