Integrity Life Sciences Announces an Additional US FDA Medical Device Clearance
TAMPA, Fla., Feb. 14, 2014 /PRNewswire-iReach/ -- Today, Integrity Life Sciences announced the addition of another US 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.
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."
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.
Team Integrity is guided by the leadership of Mr. James Gibson and a staff of managers, engineers, technicians, quality and regulatory approval professionals with a cumulative 50 plus year track record in the health care industry, with specific demonstrated success in the global Non Surgical Spinal Decompression Industry. Integrity Life Sciences manufactures its products with quality and safety standards as demonstrated by its ISO 13485 registered quality system with TUV, SUD and the CE mark affixed to its product. Our FDA clearance together with compliance to global harmonized standards of both Mark CE and ISO 13485 allows Integrity Life Sciences to distribute to countries all over the world. As the owner of multiple US Patents, Integrity Life Sciences is committed to ongoing research and development in support of the worldwide healthcare community.
Prior to Integrity Life Sciences, Mr. Gibson founded Axiom Worldwide, Inc in 2001 and obtained multiple US FDA 510(k) clearances over the years. Axiom invented its flagship products, the DRX9000 True Non-surgical Spinal Decompression System and the DRX9000C, for use in medical markets around the globe. The DRX 9000 and the DRX9000 C were created to provide relief of back and neck pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome, and sciatica. The dedicated team at Integrity Life Sciences will continue to support legacy devices while pursuing continued medical innovations throughout the world.
Integrity Life Sciences is a privately held USA based company with international partners located across the globe with a mission of "Restoring Integrity to the Spine".
For additional information please visit: www.IntegrityLifeSciences.com.
To schedule an interview please contact:
James Gibson, President & CEO
Media Contact: James Gibson, Integrity Life Sciences, 813-935-5500, James@IntegrityLifeSciences.com
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SOURCE Integrity Life Sciences