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Avitene™ Microfibrillar Collagen Haemostat

Microfibrillar Collagen Haemostat Flour

Overview
Products & Accessories
EIFU & Resources

The proven solution for controlling bleeding in all surgical applications, including neurosurgery
Trusted by surgeons for its safety and efficacy for over 40 years

Avitene™ Microfibrillar Collagen Hemostat is an active absorbable collagen hemostat, proven to accelerate clot formation. Avitene™ effectively enhances platelet aggregation and the release of proteins to form fibrin, resulting in hemostasis.

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MULTIPLE FORMS FOR EVERY SPECIALTY:

The proven solution for controlling bleeding in all surgical applications, including neurosurgery
Trusted by surgeons for its safety and efficacy for over 40 years

AVITENE™ FLOUR

Effective in controlling arterial bleeding
Conforms and adheres to irregular spaces
Easy removal with irrigation and suction

AVITENE™ SHEETS

Cut to any shape or size
Ideal for flat surfaces or to wrap vessels and anastomosis sites

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AVITENE™ ULTRAFOAM™ COLLAGEN SPONGE

Easy, effective solution for hemostasis
In an animal study, UltraFoam™ Collagen without thrombin was as effective as Gelfoam^® Sponge with thrombin
Reduced thrombin usage may lower cost
Soft, pliable sponge is ready-to-use out of the package
No soaking necessary

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INDICATIONS

AVITENE™ (MCH) is used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

CONTRAINDICATIONS

AVITENE™ (MCH) should not be used in the closure of skin incisions as it may interfere with the healing of the skin edges. This is due to simple mechanical interposition of dry collagen and not to any intrinsic interference with wound healing.
It has been reported with other collagen hemostatic agents, that by ﬁlling porosities of cancellous bone, they may signiﬁcantly reduce the bond strength of methylmethacrylate adhesives. MCH should not, therefore, be employed on bone surfaces to which prosthetic materials are to be attached with methylmethacrylate adhesives.

WARNINGS

AVITENE™ (MCH) inactivated by autoclaving.
Ethylene oxide reacts with bound hydrochloric acid to form ethylene chlorohydrin.
This device has been designed for single use only. Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient.
Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness or death of the patient or end user.
MCH is not for injection or intraocular use.
Moistening MCH or wetting with saline or thrombin impairs its hemostatic efficacy. It should be used dry. Discard any unused portion.
MCH is not intended to treat systemic coagulation disorders. Appropriate therapy to correct the underlying coagulopathy should be instituted prior to use of the product.
As with any foreign substance, use in contaminated wounds may enhance infection.

PRECAUTIONS

Only that amount of AVITENE™ (MCH) necessary to produce hemostasis should be used. After several minutes, excess material should be removed; this is usually possible without the reinitiation of active bleeding. Any excess AVITENE™ (MCH) not removed at the time of surgery may either present itself as a (recurring) mass or a (space occupying) lesion or it may lead to a foreign body reaction that may present with or without clinical signs and symptoms as a recurring mass or lesion or postoperative abscess formation upon imaging. Imaging may initially not be capable of distinguishing the difference. Removal of excess material, ideally performed upon conclusion of the initial procedure, typically resolves all signs and symptoms. Failure to remove excess MCH may result in bowel adhesion or mechanical pressure sufﬁcient to compromise the ureter. In otolaryngological surgery, precautions against aspiration should include removal of all excess dry material and thorough irrigation of the pharynx.
MCH contains a low, but detectable, level of intercalated bovine serum protein which reacts immunologically as does beef serum albumin. Increases in anti-BSA titer have been observedfollowing treatment with MCH. About two-thirds of individuals exhibit antibody titers because of ingestion of food products of bovine origin. Intradermal skin tests have occasionally shown a weak positive reaction to BSA or MCH but these have not been correlated with lgG titers to BSA. Tests have failed to demonstrate clinically signiﬁcant elicitation of antibodies of the lgG class against BSA following MCH therapy.
Care should be exercised to avoid spillage on nonbleeding surfaces particularly in abdominal or thoracic viscera.
AVITENE™ (MCH) should not be used in conjunction with autologous blood salvage circuits, as AVITENE™ may pass through the ﬁlters of such systems. It has been suggested that fragments of MCH may pass through ﬁlters of blood scavenging systems, therefore the reintroduction of blood from operative sites treated with MCH should be avoided.
The safety of this product has not been established in children or in pregnant women; therefore, MCH should only be used after an evaluation of the relative benefits and risks clearly warrant its use.
AVITENE™ non-woven web should not be used as a surface dressing except for immediate control of bleeding.
Avoid packing AVITENE™ tightly in cavities, especially within the bony enclosure of the CNS or within other relatively rigid cavities where swelling may interfere with normal function or possibly cause necrosis.
AVITENE™ is not recommended for use in patients sensitive to bovine derived collagen.The risk with respect to transmissible Spongiform Encephalopathies (TSE) has been minimized in accordance with regulatory guidelines.
Only physicians qualified in the appropriate surgical techniques should use this device.

ADVERSE REACTIONS

The most serious adverse reactions reported which may be related to the use of AVITENE™ (MCH) are potentiation of infection including abscess formation, hematoma, wound dehiscence and mediastinitis.
Other reported adverse reactions possibly related are adhesion formation, allergic reaction, foreign body reaction and subgaleal seroma (report of a single case). The use of MCH in dental extraction sockets has been reported to increase the incidence of alveolalgia. Transient laryngospasm due to aspiration of dry material has been reported following use of MCH in tonsillectomy.

RELATED PRODUCTS NOT AVAILABLE

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Absorbable Hemostatic Particles
Hemostats

BD hemostats come in various forms that all help accelerate natural clot formation in many surgical applications. They facilitate use with features such as preloaded applicators and ready-to-use designs.
Sealants

BD sealants are designed to meet the needs of clinicians in thoracic and aortic surgery
Surgical Solutions & Products

We offer a full portfolio of surgical products

Indications:

Avitene™ Microfibrillar Collagen Hemostat (MCH) and Avitene™ UltraFoam™ sponge are indicated in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Contraindications:

Avitene™ MCH and Avitene™ UltraFoam™ sponge should not be used in the closure of skin incisions as they may interfere with the healing of the skin edges. This is due to simple mechanical interposition of dry collagen and not to any intrinsic interference with wound healing.
It has been reported with other collagen hemostatic agents, that by filling porosities of cancellous bone, they may significantly reduce the bond strength of methylmethacrylate adhesives. Avitene™ MCH and Avitene™ UltraFoam™ sponge should not, therefore, be employed on bone surfaces to which prosthetic materials are to be attached with methylmethacrylate adhesives.

Warnings:

Avitene™ MCH and Avitene™ UltraFoam™ are inactivated by autoclaving.
Ethylene oxide reacts with bound hydrochloric acid to form ethylene chlorohydrin.
These devices have been designed for single use only. Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the devices and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the devices may lead to injury, illness or death of the patient or end user. Opened, unused product should be discarded.
Moistening Avitene™ MCH or wetting with saline or thrombin impairs its hemostatic efficacy. It should be used dry.
As with any foreign substance, use of Avitene™ MCH and Avitene™ UltraFoam™ in contaminated wounds may enhance infection.
Avitene™ UltraFoam™ sponge should not be used in instances of pumping arterial hemorrhage.
Avitene™ UltraFoam™ should not be used where blood or other fluids have pooled, or in cases where the point of hemorrhage is submerged as it may mask an underlying source of bleeding, resulting in hematoma.
Avitene™ UltraFoam™ sponge will not act as a tampon or plug in a bleeding site, nor will it close off an area of blood collecting behind a tampon.
Avitene™ UltraFoam™ sponge is not intended to treat systemic coagulation disorders.
Avitene™ MCH and Avitene™ UltraFoam™ are not for injection, intraocular or intravascular use.

Adverse Reactions:

The most serious adverse reaction reported which may be related to the use of Avitene™ MCH or other collagen products are potentiation of infection including abscess formation, hematoma, wound dehiscence and mediastinitis.
Other reported adverse reactions possibly related are adhesion formation, allergic reaction, foreign body reaction and subgaleal seroma (report of a single case) and increased incidence of alveolalgia when used for packing of dental extraction sockets.
Transient laryngospasm due to aspiration of dry material has been reported following use of Avitene™ MCH in tonsillectomy.

Please consult package insert for more detailed safety information and instructions for use.

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Indications:

Contraindications:

Avitene™ MCH and Avitene™ UltraFoam™ sponge should not be used in the closure of skin incisions as they may interfere with the healing of the skin edges. This is due to simple mechanical interposition of dry collagen and not to any intrinsic interference with wound healing.
It has been reported with other collagen hemostatic agents, that by filling porosities of cancellous bone, they may significantly reduce the bond strength of methylmethacrylate adhesives. Avitene™ MCH and Avitene™ UltraFoam™ sponge should not, therefore, be employed on bone surfaces to which prosthetic materials are to be attached with methylmethacrylate adhesives.

Warnings:

Avitene™ MCH and Avitene™ UltraFoam™ are inactivated by autoclaving.
Ethylene oxide reacts with bound hydrochloric acid to form ethylene chlorohydrin.
These devices have been designed for single use only. Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the devices and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the devices may lead to injury, illness or death of the patient or end user. Opened, unused product should be discarded.
Moistening Avitene™ MCH or wetting with saline or thrombin impairs its hemostatic efficacy. It should be used dry.
As with any foreign substance, use of Avitene™ MCH and Avitene™ UltraFoam™ in contaminated wounds may enhance infection.
Avitene™ UltraFoam™ sponge should not be used in instances of pumping arterial hemorrhage.
Avitene™ UltraFoam™ should not be used where blood or other fluids have pooled, or in cases where the point of hemorrhage is submerged as it may mask an underlying source of bleeding, resulting in hematoma.
Avitene™ UltraFoam™ sponge will not act as a tampon or plug in a bleeding site, nor will it close off an area of blood collecting behind a tampon.
Avitene™ UltraFoam™ sponge is not intended to treat systemic coagulation disorders.
Avitene™ MCH and Avitene™ UltraFoam™ are not for injection, intraocular or intravascular use.

Adverse Reactions:

The most serious adverse reaction reported which may be related to the use of Avitene™ MCH or other collagen products are potentiation of infection including abscess formation, hematoma, wound dehiscence and mediastinitis.
Other reported adverse reactions possibly related are adhesion formation, allergic reaction, foreign body reaction and subgaleal seroma (report of a single case) and increased incidence of alveolalgia when used for packing of dental extraction sockets.
Transient laryngospasm due to aspiration of dry material has been reported following use of Avitene™ MCH in tonsillectomy.

Please consult package insert for more detailed safety information and instructions for use.

true

Avitene™ Microfibrillar Collagen Haemostat

The proven solution for controlling bleeding in all surgical applications, including neurosurgery Trusted by surgeons for its safety and efficacy for over 40 years

MULTIPLE FORMS FOR EVERY SPECIALTY:

The proven solution for controlling bleeding in all surgical applications, including neurosurgery
Trusted by surgeons for its safety and efficacy for over 40 years