Positive results in phase III trial of Evarrest Fibrin Sealant Patch in hemostasis- Ethicon

Ethicon has announced new data from a global cardiovascular (CV) Phase III clinical trial of the Evarrest Fibrin Sealant Patch. Seventy five percent of patients treated during aortic reconstruction surgery with Evarrest achieved hemostasis on the first attempt within three minutes and maintained hemostasis throughout the duration of the surgery, as compared to 45 percent for those treated with Baxter's TachoSil.

The Evarrest CV Phase III study concludes a series of pivotal trials designed to demonstrate the fibrin sealant patch's safety and efficacy in a variety of tissue types. In the intent-to-treat primary endpoint analysis, 57 of 76 (75%) of patients treated with Evarrest achieved hemostasis within three minutes of product application. Hemostasis was maintained through the initiation of chest wall closure. Thirty six of 80 (45%) of those treated on the TachoSil arm achieved the primary endpoint. In the secondary endpoint analysis, 77.6% and 84.2% of patients treated with Evarrest achieved hemostasis at six minutes and ten minutes, respectively, and maintained hemostasis through initiation of chest wall closure. In the TachoSil arm, 56.3% and 70% of patients achieved hemostasis at six minutes and ten minutes, respectively, and maintained hemostasis through initiation of chest wall closure. No major safety concerns were identified during the study. Results from this investigational study will be presented at The Houston Aortic Symposium.

Comment: This latest evidence is part of a pending regulatory submission to the FDA to expand the indication for Evarrest in the United States. Evarrest is currently approved for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic, and non-cardiac thoracic surgery when control of bleeding by standard surgical methods of hemostasis (e.g., suture, ligature, cautery) is ineffective or impractical. If approved by the FDA, Evarrest could be used as an adjunct for general hemostasis.