Fziomed’s Oxiplex gel earned the FDA’s de novo classification and marketing authorization for lumbar spine surgery, according to a July 8 news release.
Oxiplex is the first intraoperative gel of its kind designed specifically for lumbar spine surgery and is used to reduce postoperative leg pain and neurological symptoms. The clear viscoelastic gel is absorbable and applied to tissues and surrounding anatomy during surgery right before closure. For spine patients, it acts as a temporary physical barrier between adjacent tissues.
Outside the U.S. it has been used since 2002 in more than 750,000 spine procedures.
