FDA expands indication for Evarrest Fibrin Sealant Patch for problematic bleeding during surgery- Ethicon

The FDA has approved an expanded indication for Evarrest Fibrin Sealant Patch, from Ethicon, which leverages biologics to rapidly and reliably stop problematic bleeding during surgery. The expanded indication supports the use of Evarrest as an adjunctive hemostat across a broad range of challenging patient types and surgical situations.

Evarrest demonstrated superior hemostatic efficacy on the first attempt, and consistently outperformed conventional adjunctive hemostatic methods in a broad range of challenging patient types and surgical situations, including coagulopathic and anticoagulated patients. The cardiovascular clinical study that supported the expanded indication for Evarrest demonstrated its superior hemostatic efficacy against Tachosil Fibrin Sealant Patch in a head-to-head clinical study.

In addition to superior hemostatic efficacy in controlling problematic bleeding situations, Evarrest has been shown to deliver cost savings compared with current standard of care, when taking into account hemostat cost, OR time, transfusion requirements and retreatment. The low rate of re-bleeding with Evarrest reduces the need for other adjunctive hemostats.