Avitene™ Ultrafoam™ Collagen Sponge, 50 sq cm

Animal data may not correlate to outcomes in humans. Data on file.

Indications

AVITENE™ ULTRAFOAM™ sponge is indicated in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Contraindications

• AVITENE™ ULTRAFOAM™ sponge 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 due to any intrinsic interference with wound healing. 
• It has been reported with other collagen hemostatic agents, that by fi lling porosities of cancellous bone, they may signifi cantly reduce the bond strength of methylmethacrylate adhesives. AVITENE™ ULTRAFOAM™ sponge should not, therefore, be employed on bone surfaces to which prosthetic materials are to be attached with methylmethacrylate adhesives.

Warnings

• AVITENE™ ULTRAFOAM™ sponge is 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  erformance 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. Opened, unuse  product should be discarded. 
• As with any foreign substance, use of AVITENE™ ULTRAFOAM™  ponge in  ontaminated wounds may enhance infection.  
• AVITENE™ ULTRAFOAM™ sponge should not be used in instances of pumping arterial hemorrhage. 
• It should not be used where blood or other fl uids 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. Appropriate therapy to correct the underlying coagulopathy should be instituted prior to use of the product.
• Not for injection, intraocular or intravascular use.

Precautions

• AVITENE™ ULTRAFOAM™ sponge, like other collagen hemostats, should not be left in infected sites or on infected surfaces.
• As with other hemostatic agents, it is not recommended for use in persons with known sensitivity to material of bovine origin. The risk with respect to transmissible Spongiform Encephalopathies (TSE) as been minimized in accordance with regulatory guidelines.
• Any excess AVITENE™ ULTRAFOAM™ 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.
• Microfi brillar Collagen Hemostat (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 observed following 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 IgG titers to BSA. Tests have failed to demonstrate clinically significant elicitation of antibodies of the IgG class against BSA following MCH therapy. 
• When placed into cavities or closed spaces, care should be exercised to avoid overpacking AVITENE™ ULTRAFOAM™ sponge as it may press against neighboring structures. 

• The safety of this product has not been established in children or in pregnant women; therefore, AVITENE™ ULTRAFOAM™ sponge should only be used after an evaluation of the relative benefits and risks clearly warrant its use.

• 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 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.