Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon is touting 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.
The Somerville, N.J.-based unit said it plans to use the trial data to back a bid for an expanded indication for the patch, which 1st won FDA approval in December 2012 for soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic and non-cardiac thoracic surgeries. Ethicon won an expanded indication for liver surgery in April 2015.
“This study adds to the increasing body of evidence on Evarrest and its use to control problematic bleeding situations in even the most challenging patients and surgical situations,” Ethicon medical director Dr. Richard Kocharian said in prepared remarks. “Ethicon will continue to bring meaningful innovation, like Evarrest, to more surgeons and their patients to help address significant healthcare needs.”
“Controlling bleeding in a highly complex surgical procedure, like aortic reconstruction, can be challenging,” added study investigator Dr. Sina Moainie of the St. Vincent Heart Center in Indianapolis. “Once again, Evarrest demonstrated positive results – even under the most challenging circumstances such as when applied to a prosthetic graft while on cardiopulmonary bypass and hypothermia.”
