SURGICAL HEMOSTATIC AGENT

Collagen-basedhemostatic dry powder

8, allée Irène Joliot Curie69800 Saint Priest - FranceTél. : +33 (0)4 86 57 36 10Fax : +33 (0)4 37 69 00 84 contact@biomup.comwww.biomup.com

HEMOSTATIC AGENT

DUAL ACTION OF COLLAGEN: MECHANICAL ACTION AND ACTIVATION OF COAGULATION CASCADE

READY-TO-USE POWDER* CONTAINED IN BELLOWS

CONTROL OF SLIGHT TO MODERATE BLEEDING (1)

PACKAGING:

Quantity per bellow (g) Number of bellows and applicators (25 cm) per pack Reference

1 6 HEM03C

(1) Biom’up, internal data.(2) Instruction for use HEMOSNOW™.(3) Bleeding scale based on the Adams bleeding scale. * Refer to glossary (last page).

HEMOSTATICDRY POWDER

SUITABLE FOR MOST TYPES OF SURGERY - Heart, abdominal-visceral, cardio-thoracic,

vascular, gynecological or plastic surgeries (1,2)

- Contraindicated in cases of neurosurgery and ophthalmology (2)

EASY TO APPLY (2)

- Ready-to-use*- Suitable for both laparotomy and

laparoscopy- Designed to be used once or at

several times during a surgery

FAST-ACTING - Hemostasis is obtained

in less than 6 minutes (1)

- It is recommended to apply a slight pressure (using dampened gauze). This will not hinder clot formation (2)

CONTROLS SLIGHT TO MODERATE HEMORRHAGES (3) Capillary or venous (2)

(1) Bleeding scale based on Adams bleeding scale.* Glossary:- Ready-to-use: Kept at room temperature; no mixing, preparation, heating and/or thawing required. - Simplified traceability: Traceability simplified for the healthcare centre pharmacy as no blood derivative products are used.

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POLYSACCHARIDES- Maintaining hemostasis (1)

COLLAGEN- Mechanical activation via absorption

(1) Biom’up, internal data.(2) Instruction for use HEMOSNOW™.

* Refer to glossary (last page).

(1) Adapted from: Stassen , JM, Arnout, J, Deckmyn, H. The Hemostatic System. Curr Med Chem. 2004; 11(17); 2245-2260.(2) Bleeding scale based on the Adams bleeding scale.(3) Burks, S and Spotnitz W.D Safety and Usability of Hemostats, Sealants and Adhesives, AORN J, 2014, Aug: 100, 2:160-176.(4) Spotnitz WD, Burks S. Hemostats, sealants, and adhesives: components of the surgical toolbox. Transfusion. 2008; 48 (7):1502-1516. * Refer to glossary (last page).

FT/VIIa complexIXa/VIIIa complex

PF3 released by aggregated platelets

Cross-linked fibrin polymer

Prothrombin (II)

Fibrinogen

Fibrin

Thrombin (IIa)

Prothrombin activator

X

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Xa

Abdominal surgery• Hepatic (section)• Gallbladder bed• Bariatric (staple line)

Cardio-thoracic surgery• Pulmonary lobectomy

due to malignant tumor

Except cases in neurosurgery and ophthalmology.

Pelvic surgery • Myomectomy• Endometriosis• Hysterectomy

Other• Nephrectomy• Thyroid

EXAMPLES OF INDICATIONS (2)

HEMOSNOW™ Mechanical hemostats (3,4)

Active hemostats (3,4)

Flowable hemostats (3,4)

Other surgical glues (3,4)

Composition

Porcinecollagen

+Polysaccharides

• Porcine gelatin• Bovine collagen• Regenerated

oxidized cellulose

• Starch polysaccharides

• Bovine thrombin

• Pooled human plasma thrombin

• Recombinant thrombin

• Bovine gelatin + Pooled human plasma thrombin

• Porcine gelatin (+/- Thrombin)

• Pooled human plasma fibrin

• PEG polymer• Albumin and

glutaraldehyde• Cyanoacrylate

Bleeding /

Action

Mechanical actionBarrier to blood flow and provides a surface on which

blood can clot

+ Collagen action

Barrier to blood flow and provides a surface on which blood can clot**

Converts fibrinogen to

fibrin

Mechanical+

Active

Adhesion, gluing or tissue reinforcement

Form Dry powder Sponge/Powder/ Patch Liquid/Powder Liquid/Gel Liquid/Gel

Ready touse*

Simplified traceability*

Slight (Oozing) Moderate Severe

EXAMPLES OF CLINICAL

APPLICATIONS

Bleeding scale: (2)

** Except for products composed of collagen: dual action

HEMOSTASIS

THROMBIN

COAGULATION CASCADE FOLLOWING MECHANICAL ACTION OF HEMOSNOW™ (1)

INTRINSIC PATHWAY

Endothelium vessels ruptured exposing surrounding tissue (collagen)

EXTRINSIC PATHWAY

Tissue cells traumatized causing the release of

Activation of coagulation factorsXII, XI and IX

ACTION OF COLLAGENPLATELET AGGREGATION

TISSUE FACTOR (TF)

ions

Activationof factor VII

HEMOSTATIC FOCUS

2 COMPONENTS FOR A MECHANICAL

ACTION (1)

Dr A. Dabrowski, Clinique Saint Omer

USED ON A STAPLE LINE

Pr C. Laurent, CHU de Bordeaux

USED IN LIVER SURGERY

USED ON A GALLBLADDER BED

Dr L. Dalmasso, CH de Blois

Dr L. Dalmasso, CH de Blois

USED ON THYROID LODGE