Confirmatory Clinical Study to Support the Effectiveness and Safety of Oxiplex® for the Reduction of Pain and Symptoms Following Lumbar Surgery
FzioMed is pleased to announce the enrollment of patient number one in the supportive study of Oxiplex® in patients undergoing lumbar surgery for disc herniation
SAN LUIS OBISPO, Calif., July 23, 2018 /PRNewswire/ -- Oxiplex® is an absorbable, synthetic viscoelastic gel that is applied following partial discectomy, with the intent to reduce postoperative leg pain, back pain and neurologic symptoms.
"We are pleased that we now have several active sites around the US that are participating in this supportive study that will pave the way for US approval," said John Krelle, President and CEO of FzioMed. "We are on track to have the full complement of 20 sites enrolling within the coming weeks and are confident that the trial will be a success."
Multiple US and OUS peer reviewed studies have demonstrated the benefits of Oxiplex® in a group of patients, who have higher levels of back and leg pain at baseline. These patients typically have an inferior outcome and commonly rely on additional methods of pain reduction for some time following an otherwise successful surgery. Oxiplex is designed to reduce these levels of pain and give patients greater satisfaction with the overall results of their surgery.
The study is posted on Clinicaltrials.gov.
About FzioMed, Inc.
FzioMed, Inc. is a privately held medical device company that develops, manufactures and markets absorbable adhesion barriers based on its patented polymer technology. Our products are sold in more than 70 countries. For more information visit www.fziomed.com.
FzioMed®, Oxiplex®, Oxiplex/AP®, Oxiplex/IU®, Dynavisc®, Interpose®, and Laresse® are registered trademarks of FzioMed, Inc.
SOURCE FzioMed, Inc.
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