SOMERVILLE, N.J., Oct. 25, 2016 /PRNewswire-USNewswire/ -- Ethicon* announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for EVARREST® Fibrin Sealant Patch, which leverages biologics to rapidly and reliably stop problematic bleeding during surgery. The expanded indication supports the use of EVARREST® as an adjunctive hemostat across a broad range of challenging patient types and surgical situations. This represents a significant milestone in controlling problematic bleeding situations with high confidence, while advancing patient care.
Problematic bleeding that is more than routine and resistant to conventional means of control is one of the most threatening complications of surgery2 and a frequent cause of negative patient outcomes, posing significant clinical and economic challenges.3,4 In patients treated with hemostatic agents for a variety of surgical procedures, bleeding complications were still found to occur in 32% to 68% of surgical cases.4
EVARREST® demonstrated superior hemostatic efficacy on the first attempt, and consistently outperformed conventional adjunctive hemostatic methods in a broad range of challenging patient types and surgical situations, including coagulopathic and anticoagulated patients.1 The cardiovascular clinical study that supported the expanded indication for EVARREST® demonstrated its superior hemostatic efficacy against Tachosil® Fibrin Sealant Patch in a head-to-head clinical study.1,5
"I'm usually very conservative when using new products but I think EVARREST stands out as one of those products that has made a difference in our practice," said Dr. John A. Kern, Thoracic and Cardiac surgeon at the University of Virginia (UVA) Health System. "I've used EVARREST to manage troublesome bleeding from soft tissue in the thoracic cavity and have been impressed with the results. It's incredibly effective and much easier to use than other available hemostats."
In addition to superior hemostatic efficacy in controlling problematic bleeding situations, EVARREST® has been shown to deliver cost savings compared with current standard of care, when taking into account hemostat cost, OR time, transfusion requirements and retreatment. The low rate of re-bleeding with EVARREST® reduces the need for other adjunctive hemostats.6
"The general hemostasis indication for EVARREST offers surgeons expanded options for safe and effective adjunctive hemostasis," said Oray Boston, Worldwide Vice President, Biosurgicals at Ethicon. "Ethicon offers a comprehensive portfolio of best-in-class surgical products and EVARREST is just one of many examples of how our science-based innovative solutions and high quality technologies enable surgeons to achieve superior hemostatic efficacy and improve patient care."
With the FDA's most recent approval, EVARREST® is now indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. EVARREST® also can be used in laparoscopic surgery and other minimally invasive surgeries, where manual compression can be achieved.7 Limitations for Use: Cannot safely or effectively be used in place of sutures or other forms of mechanical ligation in the treatment of major arterial or venous bleeding.
EVARREST® is part of a comprehensive portfolio of best-in-class surgical products, providing truly differentiated value to surgeons. It is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature and cautery) is ineffective or impractical.
EVARREST® represents the convergence of biologics and a medical device (flexible patch) that when combined, form an innovative product 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, providing a durable mechanical structure for integrated clot formation.7 8
To use the product, surgeons place EVARREST® upon the bleeding wound surface and apply manual compression for three minutes. EVARREST® remains in the patient's body once surgery has been completed as it is fully bioabsorbable in approximately 8 weeks.
From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the family of Johnson & Johnson companies, 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.
Last updated on: 26/10/2016
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