New Data Presented on Ethicon's EvarRest Fibrin Sealant Patch

March 9, 2016—Ethicon, a Johnson & Johnson company, announced that new data from a global cardiovascular (CV) phase 3 clinical trial of the EvarRest fibrin sealant patch were presented at The Houston Aortic Symposium, held March 3–5, 2016, in Houston, Texas. In the study, 75% of patients treated during aortic reconstruction surgery with EvarRest achieved hemostasis on the first attempt within 3 minutes and maintained hemostasis throughout the duration of the surgery, as compared to 45% for those treated with Baxter’s TachoSil.

In other company news, Ethicon announced on March 7 a definitive agreement to acquire NeuWave Medical, Inc., a privately held medical device company that manufactures and markets minimally invasive soft tissue microwave ablation systems.

The objective of this randomized, multicenter, phase 3 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 the 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 3 minutes, 6 minutes, 10 minutes, and up to the time of chest closure. Patient age ranged from 24 to 83 years, with 117 male patients and 39 female patients.

In the intent-to-treat primary endpoint analysis, 57 of 76 (75%) of patients treated with EvarRest achieved hemostasis within 3 minutes of product application. Hemostasis was maintained through the initiation of chest wall closure. 

The primary endpoint was achieved in 36 of 80 patients (45%) treated in the TachoSil arm. In the secondary endpoint analysis, 77.6% and 84.2% of patients treated with EvarRest achieved hemostasis at 6 minutes and 10 minutes, respectively, and maintained hemostasis through initiation of chest wall closure.

In the TachoSil arm, 56.3% and 70% of patients achieved hemostasis at 6 minutes and 10 minutes, respectively, and maintained hemostasis through initiation of chest wall closure. No major safety concerns were identified during the study, advised Ethicon.

In the company’s press release, study investigator Sina Moainie, MD, commented, “Controlling bleeding in a highly complex surgical procedure, like aortic reconstruction, can be challenging. Once again, EvarRest demonstrated positive result—even under the most challenging circumstances such as when applied to a prosthetic graft while on cardiopulmonary bypass and hypothermia.” Dr. Moainie is a cardiothoracic surgeon at St. Vincent Heart Center of Indiana in Indianapolis.

Surgeons place EvarRest on the bleeding wound surface and apply manual compression for approximately 3 minutes. The product remains in the patient’s body once surgery has been completed as it is fully bioabsorbable.

Ethicon stated that EvarRest represents the convergence of biologics and a 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.

According to the company, the EvarRest CV phase 3 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 US Food and Drug Administration to expand the indication for EvarRest in the United States. If approved, EvarRest could be used as an adjunct for general hemostasis.

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 noncardiac thoracic surgery when control of bleeding by standard surgical methods of hemostasis (eg, suture, ligature, cautery) is ineffective or impractical.