Data from FzioMed's Oxiplex U.S. Pivotal Clinical Study Published in Spine
Oxiplex Reduces Leg Pain, Back Pain and Associated Symptoms Following Lumbar Discectomy
SAN LUIS OBISPO, Calif.--(BUSINESS WIRE)--Apr 15, 2012 - FzioMed, Inc. today announced the publication of results from the Oxiplex® pivotal clinical study in today's issue of Spine, the leading international peer-review journal for study of the spine.
Oxiplex is an absorbable gel placed at sites of tissue injury in the epidural space during lumbar laminectomy, laminotomy and discectomy surgical procedures. Oxiplex is intended to act as a temporary barrier separating tissue surfaces to reduce pain, radiculopathy, lower extremity weakness, and the incidence and severity of postoperative adhesions.
“During spine surgery, the nerve root undergoes both physical and biochemical irritation which can lead to post-operative pain,” said John Krelle, President and CEO of FzioMed. “Oxiplex gel is used during surgery to coat and separate the sensory nerve and surrounding tissues, to reduce exposure to the irritants that cause pain.”
The Spine article reported results from a prospective, multi-center, randomized, blinded, parallel group 352-patient U.S. pivotal clinical study comparing Oxiplex-treated patients (n=177) to surgery only (n=175), to assess the safety and effectiveness of Oxiplex gel. Patients were randomly selected to receive surgery only or surgery plus Oxiplex gel placed on and around the dura and nerve root prior to wound closure. The effectiveness of Oxiplex for the reduction of pain and associated symptoms was assessed at baseline (before surgery) and at 1, 3 and 6 months following surgery using the Lumbar Spine Outcomes Questionnaire (LSOQ) and clinical evaluations.
Baseline demographics were similar and there were no differences in the safety profile between groups.
All subjects in the treatment group showed improvement including reduction of leg and back pain, fewer CSF leaks, hypoaesthesias, paraesthesias and sensory loss. There was also a significant reduction in the rate of reoperation in the Oxiplex group. The most prominent reduction of leg and back pain was seen in those patients with severe back pain at baseline. Oxiplex-treated subjects were also more satisfied with their treatment compared to the control group. Read more in the current issue of Spine.
In conclusion, improvement in clinical outcomes resulting from the use of Oxiplex gel in discectomy procedures for treatment of lumbar disc herniation was observed.
FzioMed is a privately held medical device company developing and commercializing absorbable, surgical biomaterials based on the company's patented science. FzioMed's polymer technology is used in a variety of surgical specialties including orthopedics, spine, tendon, peripheral nerve, gynecology, aesthetics and general surgery. www.fziomed.com
FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc.
Contact: FzioMed, Inc.
John Krelle, CEO and President
Posted: April 2012