Ethicon, Inc. Release: EVARREST Fibrin Sealant Patch A Potential Solution For Aortic Reconstruction Surgery
SOMERVILLE, N.J., March 10, 2015 /PRNewswire/ -- 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.
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 processthe 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.
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. 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®.
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.
 Fischer C. et al. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. J Am Coll Surg. 2013 Sep;217(3):385-93
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