EVARREST Fibrin Sealant Patch a potential solution for aortic reconstruction surgery

SOMERVILLE, N.J., March 10, 2015 -- Ethicon today announced positive new data from the clinical development program for EVARREST Fibrin Sealant Patch. More than 92 percent of patients treated during aortic reconstruction surgery with Ethicon's EVARREST achieved hemostasis on the first attempt within three minutes and maintained hemostasis throughout the duration of the surgery, compared to 33 percent for those treated with Baxter's TachoSil patch and 46 percent for those treated with the standard of care, manual compression with or without an additional topical absorbable hemostat. The results of the Phase II study, as presented on Saturday at The Houston Aortic Symposium in Houston, TX, demonstrate the potential of EVARREST as an adjunctive hemostatic agent in this challenging setting.

"These findings demonstrate the potential clinical usefulness of the EVARREST Fibrin Sealant Patch when surgically repairing an aortic aneurysm or aortic dissection," said Sina L. Moainie, M.D., cardiothoracic surgeon at St. Vincent Heart Center of Indiana in Indianapolis and one of the study's investigators. "We will continue to study EVARREST in this setting to see if the positive results persevere, but we are encouraged by the data to date."

The current standard of care for controlling anastomotic suture line bleeding in aortic reconstruction surgery includes manual compression with or without a topical absorbable hemostat. This three-arm, randomized multicenter Phase II clinical study compared the use of two human fibrinogen- and thrombin-containing fibrin sealant patch products – Ethicon's EVARREST or Baxter's TachoSil and the current standard of care method. Forty-two patients were randomized and treated during procedures involving elective repair of aortic aneurysm or aortic dissection. Patient age ranged from 29 to 83 years with 33 male patients and nine females.

In the study, the target bleeding site was defined as the first synthetic aortic graft anastomotic site with suture line bleeding, that did not respond to 30 seconds of manual compression, requiring adjunctive treatment. The site was identified and treated while patients were still on cardiopulmonary bypass and prior to heparin reversal. During the surgery, treatment in all study arms was applied with three minutes of continuous firm manual compression.  Hemostasis was assessed four different times following application (at 3, 6 and 10 minutes and up through immediately prior to initiation of final chest wall closure).

The core temperature of patients ranged from 21-38 degrees Celsius (69.8-100.4 degrees Fahrenheit), meaning a thinner patient's blood within a range of hypothermia, thereby making blood clotting more difficult. In the intent-to-treat primary endpoint analysis, 12 of 13 (92.3%) of EVARREST-treated patients achieved hemostasis within three minutes of product application. Hemostasis was maintained through the initiation of chest wall closure. Six of 18 (33.3%) of those treated on the TachoSil arm achieved the primary endpoint, while five of 11 (45.5%) achieved the primary endpoint in the standard of care arm. Despite the small sample in this study, EVARREST demonstrated a significant difference in efficacy versus the two comparator arms of the trial.

No safety signals were identified during the study. No patients treated with EVARREST experienced adverse events that were potentially related to re-bleeding at the target bleeding site or were reported as thrombotic events. Two patients treated with TachoSil had post-procedural hemorrhagic events potentially related to re-bleeding at the target site.

"Unexpected and uncontrollable bleeding during highly complex surgical procedures can present significant challenges for surgeons, and in some cases, can increase a patient's mortality rate," said Dan Wildman, Vice President, Global Franchise Strategy & Innovation for Ethicon. "The positive outcome of this research is an early sign of the unique enabling potential of EVARREST to aid surgeons in rapidly and reliably controlling problematic bleeding in cardiac surgery and even the most challenging patients and surgical situations."  

This study is a part of an ongoing IND for EVARREST and is legally sponsored by ETHICON Biosurgery clinical development organization.

About EVARREST

EVARREST is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis for soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic, and non-cardiac thoracic surgery when control of bleeding by standard surgical methods of hemostasis (e.g., suture, ligature, cautery) is ineffective or impractical.

EVARREST represents the convergence of biologics and medical device (flexible patch) that form a distinct delivery system that works together to augment the actual human coagulation system. Each component of EVARREST plays an active role in the hemostasis process—the biologics (human thrombin and fibrinogen) react and initiate a fibrin clot, which then integrate into the patch, providing mechanical support and adherence to the wound site.

To use the product, surgeons place EVARREST upon the bleeding wound surface and apply manual compression for approximately three minutes. EVARREST remains in the patient's body once surgery has been completed as it is fully bio-absorbable.

Clinical studies demonstrate that EVARREST is 98% effective as an adjunct hemostat in stopping bleeding and maintaining hemostasis for soft tissue bleeding compared to the current standard of care at 53%, potentially minimizing disruption to the surgical procedure.

About Ethicon*

Ethicon provides trusted quality, innovative technologies and education services to advance cardiovascular care. Our solutions include EVERPOINT Cardiovascular Needles with superior penetration performance and bend resistance, SURGICEL SNoW Topical Absorbable Hemostat to manage intraoperative bleeding faster, and EVICEL Fibrin Sealant (Human) to prevent post-operative re-bleeding in high-risk patients.

From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon has made significant contributions to surgery for more than 80 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues, and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact.

*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates.

Ethicon, Inc. is the legal manufacturer of EVARREST.