ADJUNCTIVE HEMOSTATS

EVARREST Fibrin Sealant Patch

Product Codes:

EVT5024

ADJUNCTIVE HEMOSTATS

EVARREST Fibrin Sealant Patch

Product Codes:

EVT5024

EVARREST is an innovative solution that can stop challenging bleeding on the first attempt1 and is backed by a variety of controlled, clinical trials, and demonstrated superior hemostatic efficacy.1-4 Hemostasis is achieved with EVARREST Fibrin Sealant Patch when the formed fibrin clot integrates with the patch component and adheres to the wound surface, thus also providing a physical barrier to bleeding.5 

EVARREST demonstrated hemostatic superiority across 4 clinical trials. Trial 1: Soft Tissue hemorrhage: Per protocol efficacy measured at n=87, 100% vs 53.3% for Surgicel Δ 46.7% P<0.0001; (ITT population=90). Trial 2: Normal and Abnormal liver resection hemorrhage: Per protocol efficacy measured at n=77, 94.3% vs 28.6% for conventional adjunctive methods Δ 65.7% P<0.001; (ITT population=84). Trial 3: Anatomic and nonanatomic liver resection hemorrhage: Per protocol efficacy measured at n=93, 97.9% vs 44.4% for conventional adjunctive methods Δ 53.5% P<.0001; (ITT population=102). Trial 4: Aortic reconstruction: Per protocol efficacy measured at n=141, 78.8% vs 46.7% for Tachosil Δ 32.1% P<0.0001; (ITT population=156).

EVARREST is an innovative solution that can stop challenging bleeding on the first attempt1 and is backed by a variety of controlled, clinical trials, and demonstrated superior hemostatic efficacy.1-4 Hemostasis is achieved with EVARREST Fibrin Sealant Patch when the formed fibrin clot integrates with the patch component and adheres to the wound surface, thus also providing a physical barrier to bleeding.5 

EVARREST demonstrated hemostatic superiority across 4 clinical trials. Trial 1: Soft Tissue hemorrhage: Per protocol efficacy measured at n=87, 100% vs 53.3% for Surgicel Δ 46.7% P<0.0001; (ITT population=90). Trial 2: Normal and Abnormal liver resection hemorrhage: Per protocol efficacy measured at n=77, 94.3% vs 28.6% for conventional adjunctive methods Δ 65.7% P<0.001; (ITT population=84). Trial 3: Anatomic and nonanatomic liver resection hemorrhage: Per protocol efficacy measured at n=93, 97.9% vs 44.4% for conventional adjunctive methods Δ 53.5% P<.0001; (ITT population=102). Trial 4: Aortic reconstruction: Per protocol efficacy measured at n=141, 78.8% vs 46.7% for Tachosil Δ 32.1% P<0.0001; (ITT population=156).

About this Device

EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.

Economic Evidence

EVARREST was associated with potential perioperative cost savings in indicated patients across a broad range of surgical specialties in clinical trials, includingA:

  • $582 in soft tissue & liver procedures6-11
  • $3,757 in soft tissue & liver coagulopathic sub-set proceduresB,C5-11
  • $3,804 in cardiovascular procedures in anti-coagulated patientsD6,12

A. Perioperative costs included operating time, retreatment, and transfusions. 
B. Net cost savings determined by comparing EVARREST to SoC based on product acquisition cost, surgery time, transfusion requirements, and retreatment effect. SoC varied across trials cited.
C. Patients potentially coagulopathic, defined by a coagulation parameter outside of normal reference range.
D. Cardiovascular surgery efficacy claims refer to head-to-head study of EVARREST and TachoSil® Fibrin Sealant Patch

 

Clinical Evidence

EVARREST demonstrated superior hemostatic efficacy in 4 randomized controlled clinical trials across a spectrum of challenging bleeding situations and surgical procedures.1-4

  • Trial 1: Soft Tissue hemorrhage (ITT population=90). 
  • Trial 2: Normal and Abnormal liver resection hemorrhage (ITT population=84). 
  • Trial 3: Anatomic and nonanatomic liver resection hemorrhage (ITT population=102). 
  • Trial 4: Aortic reconstruction (ITT population=156).

EVARREST demonstrated hemostatic superiority across 4 clinical trials. Trial 1: Soft Tissue hemorrhage: Per protocol efficacy measured at n=87, 100% vs 53.3% for Surgicel Δ 46.7% P<0.0001; (ITT population=90). Trial 2: Normal and Abnormal liver resection hemorrhage: Per protocol efficacy measured at n=77, 94.3% vs 28.6% for conventional adjunctive methods Δ 65.7% P<0.001; (ITT population=84). Trial 3: Anatomic and nonanatomic liver resection hemorrhage: Per protocol efficacy measured at n=93, 97.9% vs 44.4% for conventional adjunctive methods Δ 53.5% P<.0001; (ITT population=102). Trial 4: Aortic reconstruction: Per protocol efficacy measured at n=141, 78.8% vs 46.7% for Tachosil Δ 32.1% P<0.0001; (ITT population=156).

Features & Benefits

Proven Superior to TachoSil Patch

Proven Superior to TachoSil Patch

EVARREST was clinically proven to achieve hemostasis more reliably than TachoSil Patch in a multicenter, randomized study in aortic reconstruction surgery, achieving hemostasis in 3 minutes in 78.8% of cases vs 46.7% (per protocol; ITT population=141).13


 

Blood Seeps in, Doesn’t Pool Underneath

Blood Seeps in, Doesn’t Pool Underneath

After appropriate application and manual compression for 3 minutes, blood seeps into the EVARREST patch rather than pooling beneath it. Blood activates fibrinogen and thrombin to form a clot. Hemostasis is achieved when the clot integrates with the patch and adheres to the tissue surface.5


 

evarrest used in a surgical procedure

Offers Superior Hemostatic Efficacy on the first attempt1-4

Challenging and uncontrollable bleeding during surgery is associated with increased mortality rates.14 When challenging bleeding arrises, EVARREST offers superior hemostatic efficacy on the first attempt.1-4

EVARREST demonstrated hemostatic superiority across 4 clinical trials. Trial 1: Soft Tissue hemorrhage: Per protocol efficacy measured at n=87, 100% vs 53.3% for Surgicel Δ 46.7% P<0.0001; (ITT population=90). Trial 2: Normal and Abnormal liver resection hemorrhage: Per protocol efficacy measured at n=77, 94.3% vs 28.6% for conventional adjunctive methods Δ 65.7% P<0.001; (ITT population=84). Trial 3: Anatomic and nonanatomic liver resection hemorrhage: Per protocol efficacy measured at n=93, 97.9% vs 44.4% for conventional adjunctive methods Δ 53.5% P<.0001; (ITT population=102). Trial 4: Aortic reconstruction: Per protocol efficacy measured at n=141, 78.8% vs 46.7% for Tachosil Δ 32.1% P<0.0001; (ITT population=156).

Device Specifications and Comparisons

EVARREST™ 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.5

Select Competitive Products: TachoSil® Fibrin Sealant Patch

Featured Product

EVARREST Fibrin Sealant Patch blank space

EVARREST Fibrin Sealant Patch

Not Applicable

Codes

EVT5024

Description

Human fibrinogen and human thrombin embedded in a flexible composite patch

Indication

EVARREST 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.

Size

2in x 4in (5.1cm x 10.2cm)

Hemostatic Agent & Accessory

Hemostatic Agent

Absorption Time

Approximately 8 weeks

Storage Requirements

Store unopened packages of EVARREST at 2 to 25ºC. EVARREST does not require refrigeration. Do not freeze.

Preparation Time

Ready out of package

Shelf Life

2.5 years

Material/Composition

Human fibrinogen, human thrombin, composite patch (PG910 (VICRYL) and ORC)

Mechanism of Action

After appropriate application and manual compression for 3 minutes, blood passes through the patch, rather than pooling beneath it. Activation of fibrinogen and thrombin results in clot formation at the bleeding surface and within the patch. Adhesive strength forms a physical seal with tissue and maintains a flexible barrier to bleeding.

NDC/Distributor Code

63713-050-24

Qty./Box

2

Learn How to Use This Device

Supporting Documentation

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