Clinical Studies Underway in India
TAMPA, Fla., Jan. 23, 2013 /PRNewswire-iReach/ — Integrity Life Sciences announced today that data collection continues in a single-site prospective study relating to Non-Surgical Spinal Decompression in Bangalore, India. The study is being conducted using Integrity Life Sciences’ Non-Surgical Spinal Decompression system which received US FDA 510(k) clearance in early 2011.
The study site, Dr. Ahmed’s Wellcare Orthopaedic Centre, was selected based on its integrated approach in treating patients suffering from chronic lumbar and cervical pain. Dr. Ahmed’s Wellcare Orthopaedic Centre is one of the premier orthopaedic health care institutions in India providing top quality specialized service and comprehensive care that is both curative and preventive in nature. Located in the heart of Bangalore, the garden city and the IT capital of India, Dr. Ahmed’s Wellcare Orthopaedic Centre caters to the specific needs and demands of domestic and international patients and focuses on non-surgical alternatives in treating disc related problems of the spine.
While the study is scheduled to continue throughout 2013, the early evaluation of the results in 100 prospective patients with lumbar or cervical disc prolapse are encouraging regarding Non-Surgical Spinal Decompression therapy. According to Integrity Life Sciences’ president, Mr. James Gibson, “based on the information we are receiving from Dr. Ahmed and his associates, the results are consistent with existing clinical data that demonstrate the effectiveness of NSSD therapy for patients suffering with herniated disc, sciatica, facet syndrome and degenerative disc disease. We are pleased that the Integrity system is being used for the study and, like many in the international healthcare community, we are very eager to see the final results.”
Dr. Ashfakh Ahmed, MBBS, M.S, M.Ch is the Medical Director and Chief Orthopaedic Surgeon for Dr. Ahmed’s Wellcare Orthopaedic Centre. Dr. Ahmed’s other affiliations include:
- Ex – Asst. Professor of Orthopaedics – Govt of Karnataka, Bangalore
- Visiting Consultant – Manipal Hospital, Fortis Hospital & Santosh Hospital
- Head of Department & Chief Orthopaedic Surgeon – Sabhaya Hospital
- Honorary Medical Advisor – Judo Association of Krnataka
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 (ISCS 2.0) and the Lombare System. Both 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 with Integrity Life Sciences, please contact:
James Gibson, President & CEO
To reach Dr. Ahmed’s Wellcare Orthopaedic Centre, please contact:
Dr. Ashfakh Ahmed, Medical Director
telephone: +91 98450 36378
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SOURCE Integrity Life Sciences, LLC