Fziomed received De Novo classification and marketing authorization from FDA for Oxiplex gel, indicated for reducing postoperative leg pain and neurological symptoms in adult patients undergoing lumbar spine procedures. Oxiplex is now the first and only FDA authorized intraoperative gel specifically designed for this indication.
Fziomed’s Oxiplex is an absorbable, clear viscoelastic gel applied to tissues and surrounding anatomy 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 750,000 spine procedures worldwide for postoperative adhesion prevention.
“The FDA De Novo process is a rigorous regulatory pathway utilized when there is no substantially equivalent predicate device to reference,” said Paul Mraz, President and CEO. “To satisfy FDA’s benefit-risk criteria, Fziomed submitted Level 1 clinical evidence from multiple U.S. randomized clinical trials, along with international post-marketing studies, demonstrating Oxiplex’s strong safety profile and clinical benefit. With this robust clinical evidence and over 20 years of real-world use outside the United States, we are confident Oxiplex has the potential to become a new standard of care as an adjunctive therapy.”
Fziomed received De Novo classification and marketing authorization from FDA for Oxiplex gel, indicated for reducing postoperative leg pain and neurological symptoms in adult patients undergoing lumbar spine procedures. Oxiplex is now the first and only FDA authorized intraoperative gel specifically designed for this indication.
Fziomed's...
Fziomed received De Novo classification and marketing authorization from FDA for Oxiplex gel, indicated for reducing postoperative leg pain and neurological symptoms in adult patients undergoing lumbar spine procedures. Oxiplex is now the first and only FDA authorized intraoperative gel specifically designed for this indication.
Fziomed’s Oxiplex is an absorbable, clear viscoelastic gel applied to tissues and surrounding anatomy 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 750,000 spine procedures worldwide for postoperative adhesion prevention.
“The FDA De Novo process is a rigorous regulatory pathway utilized when there is no substantially equivalent predicate device to reference,” said Paul Mraz, President and CEO. “To satisfy FDA’s benefit-risk criteria, Fziomed submitted Level 1 clinical evidence from multiple U.S. randomized clinical trials, along with international post-marketing studies, demonstrating Oxiplex’s strong safety profile and clinical benefit. With this robust clinical evidence and over 20 years of real-world use outside the United States, we are confident Oxiplex has the potential to become a new standard of care as an adjunctive therapy.”
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