Fziomed Secures FDA Approval for Innovative Oxiplex® Gel in Spine Surgery

Fziomed Secures FDA Approval for Oxiplex® Gel



Fziomed, Inc., a global leader in postsurgical adhesion prevention, recently announced a significant milestone in the medical industry: the U.S. Food and Drug Administration (FDA) has granted De Novo classification and marketing authorization for its product, Oxiplex® gel. This approval marks Oxiplex as the first and only intraoperative gel authorized by the FDA specifically aimed at reducing postoperative leg pain and neurological symptoms in adults undergoing lumbar spine procedures.

The De Novo classification process is a rigorous regulatory pathway that provides approval for medical devices when there is no equivalent counterpart already on the market. Fziomed submitted robust clinical evidence involving multiple randomized clinical trials conducted in the U.S., alongside international post-marketing studies that demonstrated the gel's strong safety profile and clinical benefits. According to Paul Mraz, President and CEO of Fziomed, the blend of over 20 years of real-world applications outside the United States, combined with extensive clinical data, positions Oxiplex to potentially become the new standard of care in spine surgery.

The Importance of Oxiplex in Spine Surgery



The medical community is welcoming this innovation. Dr. Jeffrey Fischgrund, Chairman of the Orthopedic Department at William Beaumont University Hospital and principal investigator in the clinical studies, emphasized that the arrival of Oxiplex will help address a significant unmet need within spine surgeries. With its ability to effectively reduce postoperative leg pain and neurological symptoms, Oxiplex offers surgeons a pivotal tool in improving patient outcomes. As a clear, easy-to-use, and absorbable viscoelastic gel, Oxiplex is applied directly to the tissue and surrounding areas right before surgical closure. Its role as a temporary barrier between adjacent tissues has been backed by numerous peer-reviewed studies, reinforcing its impact.

Since its introduction in international markets in 2002, Oxiplex has been employed in over 750,000 spine procedures worldwide, setting the foundation for its application in the United States.

Looking Ahead



Dr. Gere diZerega, Medical Director of Fziomed, is pleased with the FDA's De Novo grant, viewing it as a culmination of years of clinical and regulatory effort. This approval also paves the way for expanding their platform of intraoperative gel technologies to other surgical disciplines such as tendon, nerve, women's health, and general surgery. The potential advantages of Oxiplex are considerable, as it can significantly enhance the quality of care patients receive during spine procedures.

Fziomed is optimistic about the road ahead. Ron Haynes, Executive Chairman and co-Founder, expressed excitement regarding the FDA’s approval and shared confidence in the capabilities of their dedicated team and the scientific rigor behind Oxiplex. The introduction of such innovative medical technologies not only showcases Fziomed's leadership in the field but also illustrates their commitment to enhancing surgical excellence and improving health outcomes for patients.

In conclusion, Fziomed's Axiplex gel approval by the FDA symbolizes a transformative step in the realm of spine surgery. With its robust clinical evidence and expansive international use, Oxiplex is poised to create a lasting impact in the operating room, fostering improved postoperative experiences for countless patients. As Fziomed continues to innovate, the medical community watches closely, anticipating further advancements that can revolutionize surgical practices and enhance patient care.

For more information about Fziomed and their leading medical products, please visit fziomed.com.

Topics Health)

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