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Integrity LifeSciences receives additional FDA clearance for spine care system

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Integrity LifeSciences announced the additional FDA clearance for its Integrity Spinal Care System for the treatment of spine and disc related conditions.

According to a company press release, the initial FDA clearance for the Integrity Spinal Care System (ISCS) was for a nonsurgical medical device that applied 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 target the lumbar spine. The company submitted the application for an additional 510(k) clearance in response to market demand.

“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,” Gary Dixon, vice president of sales and marketing of Integrity LifeSciences, stated in the release.