Ethicon won an expanded indication for its Evarrest fibrin sealant patch to include its use it as a tool to help control bleeding during adult liver surgery.
The Johnson & Johnson (NYSE:JNJ) subsidiary has had 510(k) clearance since late 2012 to use Evarrest to stop unexpected and uncontrollable bleeding during non-cardiac surgery.
Ethicon said Evarrest boosts the standard of care but also helps save money because it can reduce the need for transfusions, additional treatments, and the need to address repeat bleeding incidents. In March, the company touted positive results from a Phase II trial testing Evarrest for aortic reconstruction surgery.
"We see Evarrest as a game changer – better equipping surgeons to handle bleeding, thereby potentially improving patient outcomes, reducing [operating room] costs and providing peace of mind for the entire surgical staff," Ethicon vice president Dan Wildman said in prepared remarks.
Studies that show Evarrest is more than 94% effective in controlling bleeding in various critical patient groups and surgical scenarios, Ethicon said. The current standard of care comes in at less than 54%, according to the company.
Evarrest is bio-absorbable, blending biologics (human thrombin and fibrinogen) and medical device (the flexible patch). It works within 3 minutes to stop bleeding, Ethicon said.
