Johnson & Johnson (JNJ) Announces Additional FDA Indication for EVARREST Fibrin Sealant Patch

Johnson & Johnson (NYSE: JNJ) announced the following Monday:

Unexpected and uncontrollable bleeding is an ongoing challenge for surgeons, including those who perform liver surgery. Based on recent data, the U.S. Food and Drug Administration has approved an additional indication for Ethicon's EVARREST Fibrin Sealant Patch, as an adjunct to hemostasis for control of bleeding during adult liver surgery. EVARREST is a novel convergence of biologics and medical device that rapidly and reliably stops problematic bleeding during surgery on the first attempt in indicated patients.

A problematic bleeding situation—involving bleeding that is more than routine and resistant to conventional means of control—is one of the most threatening complications of surgery1 and a frequent cause of negative patient outcomes, posing significant clinical and economic challenges.2,3 First attempts to control surgical bleeding using current hemostatic agents can fail up to 50 percent of the time.3

"The liver is a particularly hard-to-control bleed site during surgery, as blood loss is often higher and hemostasis may be difficult to achieve," said Krishna Athota, M.D.*, trauma and critical care surgeon at the University of Cincinnati College of Medicine. "This expanded indication for EVARREST reinforces this innovation's potential to make problematic bleeding situations routine, and could result in a paradigm shift in the treatment of bleeding during surgery."

EVARREST is a novel, bioabsorbable hemostat that delivers a powerful combination of hemostatic efficacy, adherence and mechanical strength.4,5,6 The unmatched mechanism of action behind EVARREST drives rapid and durable clot formation by augmenting the human coagulation system. The technology is comprised of a flexible composite patch, which contains embedded human biologics (human thrombin and fibrinogen), which are proteins involved in the natural clotting process.

Clinical studies demonstrate that EVARREST is greater than 94 percent effective in controlling bleeding across challenging patient types and surgical situations, compared to current standard of care (less than 53 percent).7,8,9 EVARREST provides a rapid, predictable solution for problematic bleeding, minimizing surgical procedure disruption.3,7,8

"We see EVARREST as a game changer—better equipping surgeons to handle bleeding, thereby potentially improving patient outcomes, reducing OR costs and providing peace of mind for the entire surgical staff," said Dan Wildman, Vice President of Global Franchise Strategy and Innovation for Ethicon.

EVARREST has been shown to deliver a 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 hemostatic therapies.10

References:


1 Schreiber MA, Neveleff DJ. Achieving hemostasis with topical hemostats: making clinically and economically appropriate decisions in the surgical and trauma settings. AORN J. 2011;94(5):S4-S20.2 Stokes, et al. Impact Of Bleeding-Related Complications And/Or Blood Product Transfusions On Hospital Costs In Inpatient Surgical Patients. BMC Health Services Research 2011, 11:135.3 Data on File, Ethicon, Inc. Global Health Economics and Market Access. EVARREST® Fibrin Sealant Patch. Global Value Dossier Slide Deck.4 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):385-93.5 Koea JB, Batiller J, Patel B, et al. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013;15(1):61–70.6 Koea JB. Oral Presentation. 11th E-AHPBA Congress; April 21–24, 2015; Manchester, UK.7 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):385-93.8 Koea JB, Batiller J, Patel B, et al. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013;15(1):61–70.9 Koea JB. Oral Presentation. 11th E-AHPBA Congress; April 21–24, 2015; Manchester, UK.10 Corral M et al. Cost Analysis of a Fibrin Sealant Patch for Mild, Moderate and Problematic Soft Tissue Surgical Bleeding: A Hospital Perspective, Cornerstone Research Group.