Johnson & Johnson ’ s Ethicon wins FDA nod for expanded Evarrest indication

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it won an expanded indication from the FDA for its Evarrest fibrin sealant patch, now cleared for use as an adjunctive hemostat across a “broad range” of challenging patient types and surgical situations.
The company touted the win as a significant milestone in controlling problematic bleeding situations “with high confidence.”
“I’m usually very conservative when using new products but I think Evarrest stands out as one of those products that has made a difference in our practice. I’ve used Evarrest to manage troublesome bleeding from soft tissue in the thoracic cavity and have been impressed with the results. It’s incredibly effective and much easier to use than other available hemostats,” Dr. John Kern of the University of Virginia Health System said in a press release.
Ethicon said that its Evarrest patch has demonstrated “superior hemostatic efficacy” on the 1st attempt and has regularly outperformed conventional adjunctive hemostatic methods. The expanded indication was supported by a cardiovascular clinical study which showed the patch to be superior when compared head-to-head to the Tachosil fibrin sealant patch.
“The general hemostasis indication for Evarrest offers surgeons expanded options for safe and effective adjunctive hemostasis. Ethicon offers a comprehensive portfolio of best-in-class surgical products and Evarrest is j...

Source: Mass Device - October 25, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Surgical Ethicon Johnson & Johnson Source Type: news