Results from Study Evaluating Fziomed’s Oxiplex Gel

Fziomed announced results from a prospective, randomized, double-blinded, multi-center clinical study demonstrating that Oxiplex intraoperative gel improves pain and neurological outcomes for patients with severe leg and back pain when used as an adjuvant during lumbar spine surgery.

The study evaluated 134 patients undergoing surgery for lumbar disc herniation. Patients receiving Oxiplex in addition to surgery experienced higher rates of substantial and complete leg pain relief, as well as neurological symptom improvement, compared with those who underwent surgery alone. No differences in safety or adverse events were observed between the two groups.

Oxiplex is an absorbable, clear gel applied directly to nerves and surrounding tissues during surgery immediately prior to closure. In spine surgery, Oxiplex acts as a temporary physical barrier between adjacent tissues and has been shown in multiple peer-reviewed publications to reduce postoperative leg pain and neurological symptoms. Oxiplex gel has been available outside the United States since 2002 and has been used in more than 800,000 spine procedures worldwide for postoperative adhesion prevention.

“These results reinforce the importance of addressing the inflammatory microenvironment immediately following lumbar spine surgery,” said Stephanie Cortese, Senior Vice President of Science and Technology at Fziomed. “By reducing nerve exposure to early inflammatory mediators, Oxiplex has the potential to improve longer-term outcomes for patients who might otherwise experience persistent residual pain despite a technically successful surgery.”

Source: Fziomed, Inc.