FDA Expands Indication for Ethicon’s Bleeding Control Sealant Patch

The FDA has approved an expanded indication for Ethicon’s Evarrest fibrin sealant patch, which allows it to be used as an adjunct to hemostasis for bleeding control during adult liver surgery, the devicemaker announced Monday.

Evarrest is comprised of a flexible composite patch containing human proteins involved in natural clotting, thrombin and fibrinogen. These features allow it to augment the human coagulation system and spearhead clot formation, the company said, adding that the product is fully bioabsorbable into the patient’s body.

Problematic bleeding situations —  where bleeding is out of the ordinary and resistant to conventional controls — are among the most threatening surgery complications, with first-attempt hemostatic control agents failing as much as 50 percent of the time.  Evarrest consistently stops bleeding during the first attempt, Ethicon claims.

However, Evarrest cannot be used in place of sutures or other types of mechanical ligation in major arterial or venous bleeding treatment.

In clinical studies, Evarrest showed a greater than 94 percent bleeding control efficacy, in a range of challenging patient types and surgical situations, when compared to current standard of care, which displayed a less than 53 percent efficacy, Ethicon claims. The patch also allowed for better cost-effectiveness, decreased OR time, lower transfusion requirements and fewer retreatments.

FDA-approved in 2012, Evarrest previously was indicated as an adjunct to hemostasis for soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic and non-cardiac thoracic surgery. The patch received the CE Mark for a wide range of indications in 2014, with a European launch planned for later this year, a spokesperson told Device Daily on Monday.

Ethicon is a Johnson & Johnson subsidiary. — Jason Scott