SOMERVILLE, N.J., March 5, 2016 /PRNewswire/ -- Ethicon* today announced new data from a global cardiovascular (CV) Phase III clinical trial of the EVARREST® Fibrin Sealant Patch. Seventy five percent of patients treated during aortic reconstruction surgery with EVARREST® achieved hemostasis on the first attempt within three minutes and maintained hemostasis throughout the duration of the surgery, as compared to 45 percent for those treated with Baxter's TachoSil®. Results from this investigational study will be presented at The Houston Aortic Symposium.
The EVARREST® CV Phase III study concludes a series of pivotal trials designed to demonstrate the fibrin sealant patch's safety and efficacy in a variety of tissue types. This latest evidence is part of a pending regulatory submission to the U.S. Food and Drug Administration ("FDA") to expand the indication for EVARREST® in the United States.
EVARREST® is currently approved for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and 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. If approved by the FDA, EVARREST® could be used as an adjunct for general hemostasis.
"Controlling bleeding in a highly complex surgical procedure, like aortic reconstruction, can be challenging," said Sina Moainie, M.D., cardiothoracic surgeon at St. Vincent Heart Center of Indiana in Indianapolis and one of the study's investigators. "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."
The objective of this randomized multicenter Phase III clinical study was to evaluate the hemostatic efficacy and safety of EVARREST® as an adjunct to conventional hemostasis for anastomotic suture line bleeding during aortic reconstruction surgery. A total of 156 patients from North America, Europe and Asia were randomized to either EVARREST® or TachoSil. In this study, the treated target bleeding sites were aortic graft anastomotic suture line bleeding identified upon cardiac reperfusion and while on cardiopulmonary bypass. Hemostasis at the target bleeding site was assessed at three minutes, six minutes, ten minutes and up to the time of chest closure. Patient age ranged from 24 to 83 years with 117 male patients and 39 females.
In the intent-to-treat primary endpoint analysis, 57 of 76 (75%) of patients treated with EVARREST® achieved hemostasis within three minutes of product application. Hemostasis was maintained through the initiation of chest wall closure. Thirty six of 80 (45%) of those treated on the TachoSil arm achieved the primary endpoint. In the secondary endpoint analysis, 77.6% and 84.2% of patients treated with EVARREST® achieved hemostasis at six minutes and ten minutes, respectively, and maintained hemostasis through initiation of chest wall closure. In the TachoSil® arm, 56.3% and 70% of patients achieved hemostasis at six minutes and ten minutes, respectively, and maintained hemostasis through initiation of chest wall closure.
No major safety concerns were identified during the study.
"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," said Dr. Richard Kocharian, Franchise Medical Director, Ethicon. "Ethicon will continue to bring meaningful innovation, like EVARREST®, to more surgeons and their patients to help address significant healthcare needs."
EVARREST® represents the convergence of biologics and medical device (flexible patch) that when combined, form a distinct delivery system that will raise the standard of care for surgeons and their patients. 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.
From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon has made significant contributions to surgery for more than 60 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. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon.
*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®. All other trademarks are the property of their respective owners.
Important Safety Information
For topical use only. Do not apply intravascularly.
Do not use to treat bleeding from large defects in arteries or veins.
Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.
Thrombosis can occur if absorbed systemically.
Can cause hypersensitivity reactions including anaphylaxis.
Avoid application to contaminated areas of the body or in the presence of active infection. Infection can occur.
EVARREST contains oxidized regenerated cellulose which adheres to bleeding surfaces. Inadvertent adhesions can occur.
Avoid use in closed spaces where swelling may cause compression.
Use the least number of patches required to cover entire bleeding area. Do not use more than four patches.
May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
The most common adverse reactions reported during clinical trials (≥1%) were abdominal distension, blood fibrinogen increased, post procedural and intra-abdominal hemorrhage, and pulmonary embolism.
Please see package insert for EVARREST Full Prescribing Information.
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the EVARREST® Fibrin Sealant Patch. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in new product development, including obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2014, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Ethicon, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.