Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today that the FDA approved an expanded indication for its Evarrest fibrin sealant patch as an supplementary hemostat.
With the expanded indication, the patch can be used with manual compression as an adjunct to hemostasis in adult surgery patients, when standard surgical techniques to control bleeding such as suture or ligature are ineffective. The fibrin sealant patch uses biologics to rapidly stop problematic bleeding while a patient is undergoing surgery. The drug device reacts human thrombin and fibrinogen to form a fibrin clot, providing a structure for clot formation.
The clinical study that supported the FDA’s decision to expand Evarrest’s indication compared it to Tachosil fibrin sealant patch in a head-to-head comparison. The cardiovascular trial demonstrated that Evarrest had superior hemostatic efficacy. The patch also outperforms conventional supplementary hemostatic methods and delivers cost savings compared with the current standard of care, the J&J subsidiary said.
“The general hemostasis indication for Evarrest offers surgeons expanded options for safe and effective adjunctive hemostasis,” Ethicon’s worldwide VP of biosurgicals Oray Boston said in prepared remarks. “Ethicon offers a comprehensive portfolio of best-in-class surgical products and Evarrest is just one of many examples of how our science-based innovative solutions and high quality technologies enable surgeons to achieve superior hemostatic efficacy and improve patient care.”
