HemCon Bandage Overview

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HEMCON BANDAGE PRO

The Hemostatic HemCon® Bandage PRO
In the United States, loss of blood – hemorrhaging – is a main cause of death, second only to trauma injuries. The hemostatic HemCon Bandage PRO provides a patient with the time needed to either reach care or gain the critical time to clot. The HemCon Bandage PRO provides the medical professional a solution that is quick-acting, natural, localized and effective. In addition to providing hemostasis, HemCon dressings also offer an antibacterial barrier against a wide range of microorganisms including MRSA, VRE, A. baumannii (only single strains of most species have been studied).

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HemCon Bandage PRO is easy to apply, and are effective to stop even the most severe bleeding.

For your everyday needs take a look at our over-the-counter product HemCon Strip First Aid

Available Sizes: Patch | 2 x 2 inch | 2 x 4 inch | 4 x 4 inch

Features & Benefits

How it Works

Instructions for Use

Technical Information

FAQ

Features	Benefits
Stops bleeding (moderate to severe)	Saves lives
Controls blood loss	Reduces need for costly transfusions
	Provides critical time to administer care
	Proven effective with patients on anti-coagulants
Safe for use	Provides an antibacterial barrier
	Contains no human or bovine clotting factors
	No adverse affects reported in field use
Localized solution	No systemic reactions
Non-exothermic (non-heat producing)	Will not cause additional tissue damage
Simple application	Easy to administer with current protocol of dressing and pressure
Flexible and conformable to tissue surfaces	Provides flexibility at the point of care
Removal with water or saline	Simple removal keeps clot intact
Individually wrapped	Ready for use when needed

General FAQ’s for the HemCon® Bandage PRO
(addressing the 2 x 2 inch, 2 x 4 inch, 4 x 4 inch)

What was the impetus for the development of the HemCon Bandage PRO?
Out of a need to save lives, the HemCon Bandage PRO was developed. In 2001 the U.S. Army and the Institute for Surgical Research (ISR) partnered with HemCon Medical Technologies, Inc. to address the needs of soldiers who were having bleeding issues and dying in the field before they could be triaged for surgical intervention. HemCon received the second fastest FDA clearance within 48 hours and has saved hundreds of lives since.

What is the use of the HemCon Bandage PRO?

The HemCon Bandage PRO is used to save lives on the battlefield and the civilian emergency world by controlling severe bleeding from traumatic injuries. In comparison to other traditional bandages, the HemCon Bandage PRO provides superior control of bleeding, quickly seals wounds and is compatible with multiple wound site usage.

From what is the HemCon Bandage PRO comprised?

The HemCon Bandage PRO is fabricated from chitosan, a naturally occurring, biocompatible polysaccharide derived from shrimp shells. The shrimp shells are processed and chemically treated. Once in bandage form, they are sterilized.

Pandalus borealis (also called Pandalus eous) is the species of shrimp found in cold parts of the North Atlantic Ocean that is used in our chitosan.

Is there a problem using this product on people with shrimp or shellfish allergies?
There have been no known allergic reactions as a result of using the HemCon Bandage PRO since distribution began in 2003 and there have been no adverse effects reported in over 700,000 bandages shipped.

HemCon, Inc. has results from a shellfish allergy study conducted by its chitosan supplier which demonstrates that, out of 221 individuals with suspected hypersensitivity, including 8 individuals with known shellfish allergies, none demonstrated any dermal sensitivity when pricked with a chitosan test solution. However, since chitosan is extracted from the shells of shrimp and other shellfish, individuals with known shellfish allergies should exercise caution in the use of products containing chitosan.

How does the HemCon Bandage PRO work?

The chitosan in the HemCon Bandage PRO has a positive charge, and attracts red blood cells, which have a negative charge. The red blood cells create a seal over the wound as they are drawn into the bandage, forming a very tight, adherent seal. By quickly sealing the wound, the bandage reduces blood loss, and thus the demand for blood transfusion products such as red blood cells or plasma.

Can all HemCon Bandage PRO be used internally?

HemCon Medical Technologies, Inc. also offers a variety of hemorrhage control dressings, but only GuardaCareXR® Surgical is cleared with the FDA as a temporary surgical dressing to control severe bleeding in surgery and can therefore be left on the wound for up to 24 hours. All HemCon Bandage PRO from HemCon are FDA cleared as an external dressing for the temporary control of bleeding.

Is the HemCon Bandage PRO absorbable?
No, the HemCon Bandage PRO is not absorbable.

Who currently is using HemCon Bandage PRO?

In 2005, the Army Surgeon General mandated that every deployed U.S. Army soldier carry at least one HemCon Bandage PRO and every medic five. In 2007, HemCon Bandage PRO was added to every soldier’s IFAK (individual first aid kit). The product is currently being used in the civilian market by first responders, emergency departments and as of July 2007 is exclusively offered to the acute care and hospital market by Cardinal Health.

Is the HemCon Bandage PRO kosher?

The HemCon Bandage PRO is made from shellfish, a creature that is considered forbidden from consumption by some religious groups. Although the bandage is not technically consumed, it is not considered kosher.

How long does it take for the bandage to control the bleeding?

The HemCon Bandage PRO is durable, easy to use and capable of controlling hemorrhaging until an injured patient can be transported to and stabilized in a hospital. The HemCon Bandage PRO controls bleeding within 2-5 minutes.

If the HemCon Bandage PRO stops the bleeding, how does the wound heal?

The HemCon Bandage PRO is cleared by the FDA for up to 48 hours of use to control severe bleeding and is not intended for long term application to promote wound healing. The bandage provides rapid control of severe bleeding by sealing the wound. The bandage works independently of the clotting cascade, allowing the body’s natural clotting to occur.

How long can the HemCon Bandage PRO be left in place?

The bandage can be left on the wound for up to 48 hours.

How is the HemCon Bandage PRO removed?

The HemCon Bandage PRO can be easily removed with saline or water.

Is there any effect of cold temperatures on the bandage?

Although we would not expect low temperature storage conditions to affect dressing efficacy when used at room temperature and above, we have not conducted low temperature stability studies.

Is there any effect of hot temperatures on the HemCon Bandage PRO?

HemCon Bandage PRO has a long shelf life and are durable in varied temperature because they originally designed for military use. HemCon Bandage PRO is best stored at room temperature:
52 degrees F (11 degrees C) to 78 degrees F (26 degrees C).

Will the HemCon Bandage PRO work on hypothermic patients?

Although we would expect the bandage to work on hypothermic patients, we have not conducted any clinical studies to demonstrate efficacy.

Are there any contraindications for its use?

There are no known contraindications for use of the HemCon Bandage PRO. The warning and cautions on our product labels read as follows:

Do not use if seal is broken and/or contents are wet. Do not apply over eyes. Use promptly after opening. Contains chitosan from shellfish. For external use only, do not implant. Not for consumption, do not eat. Single use only. Do not resterilize.