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 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,” Ethicon biosurgicals worldwide veep Oray Boston said in a prepared statement.

With the new approval, the Evarrest patch is now indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, which blood control through conventional surgical techniques is deemed ineffective or impractical.

In March, Ethicon touted a Phase III clinical study of its Evarrest fibrin sealant patch in surgeries to repair the aorta, saying the patch handily beat Baxter‘s (NYSE:BAX) competing TachoSil product.

Ethicon said the 156-patient Evarrest CV trial showed that hemostasis was achieved within 3 minutes and maintained throughout the surgery for 75% of the Evarrest cohort, compared with 45% for the TachoSil arm. The study tracked aortic graft anastomotic suture line bleeding at 3 minutes, 6 minutes, 10 minutes and until closure. Ethicon said Evarrest also met a secondary endpoint in the trial, hemostasis at 6 and 10 minutes, at 77.6% and 84.2%, respectively, compared with 56.3% and 70% for patients treated with TachoSil. There were no major safety concerns, the company said.

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