Clinical studies underway in India

January 27, 2013 — Integrity Life Sciences announced 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 U.S. 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 .

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 is encouraging. According to Integrity Life Sciences’ president, 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.”

Source: Integrity Life Sciences, integritylifesciences.com