Ethicon, a New Jersey-based subsidiary of healthcare giant Johnson & Johnson, received approval from the United States Food and Drug Administration (FDA) for its Evarrest fibrin sealant patch. The Evarrest patch is designed to stop uncontrolled bleeding during surgical procedures.
According to a press release by the company, the Evarrest fibrin sealant patch includes a specialized biologic coating. This coating promotes the formation of a fibrin clot. By promoting the formation of a fibrin clot, the patch is able to stop severe bleeding that can’t be controlled by other methods. Ethicon will promote the product for use in situations where traditional surgical techniques are impractical or ineffective. According to clinical studies of the technology, the Evarrest surgical patch can stop bleeding with 98 percent efficacy. This compares to 53 percent efficacy for current blood-stoppage techniques.
Dan Wildman is president of Ethicon. In prepared remarks, he said, "The FDA approval of Evarrest is a significant milestone in advancing patient care. We believe this technology has the potential to drive a paradigm shift in the treatment of problematic bleeding during surgery.” He continued, "Evarrest combines the company's expertise in biomaterials and plasma-derived biologics to bring true innovation to surgeons and their patients."
While the patch is appropriate for most patients, the FDA did not approve its use in patients less than one month old. The company also noted that the patch is not a replacement for sutures in the treatment of severe bleeding.
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