Antema® is an equine collagen fleece for rapid and complete haemostasis during surgical operations. Use of topical haemostatics has the advantage that systemic interference with the coagulation mechanism can be avoided and is the ideal choice in most situations.
Antema® is made of type I collagen in its natural triple helix structure. The used collagen has a low glycosilation coefficient (less than 0.3%) and is not cross-linked. Surgical patients treated with Antema® have shown no presence of anti-collagen antibodies after one year.
Features
equine collagen fleece
prompt effective haemostasis
immediate control of haemocoagulation, tissue repair and healing
active in patients with haemocoagulation defects
non-allergic
Indications
Antema® is indicated as a haemostatic adjuvant in surgical operations, for the control of capillary haemorrhages and haemorrhages of parenchymal and vascular organs. Antema® is also active in patients with haemocoagulation defects.
Antema® has been successfully used in a variety of surgical specialities: general and abdominal surgery, traumatological and orthopaedic surgery, plastic and reconstructive surgery, vascular and cardiovascular surgery, urological and gynaecological surgery, neurosurgery, dermatology, dental surgery, colo-proctological surgery, etc..
Haemostasis
By activating factors XII and VIII, collagen contributes to the acceleration of the intrinsic pathway of the “cascade” mechanism leading quickly (2-6 minutes) to the formation of the fibrin network and to the consolidation of the clot. In tests type I collagen has been shown to have an important haemostatic action on both, healthy subjects and on those treated with anticoagulants It produces a rapid and effective haemostasis with an excellent capacity for the absorption of liquids, perfect adhesion to lesions and great reduction of blood loss.
Due to its strong platelet aggregation action and its ability to activate important factors of the coagulation system Antema® provides an excellent haemostatic agent in both, primary and secondary haemostasis.
Tissue Repair
Antema® intervenes directly in the various stages of the tissue repair process: haemostasis, inflammation, proliferation of fibroblasts, re-epithelization and synthesis of new connective tissue.
Type I collagen constitutes the ideal substrate for tissue repair due to its capacity to interact with fibroblasts, chondroblasts and osteoblasts receptors responsible for the synthesis of the connective tissue structures. These structures adhere to the heterologous collagen fibres and proliferate and orientate in order to reshape the damaged tissue. The presence of Antema® in the treated area promotes the production of homologous connective tissue, in which the stem cells of the damaged parenchyma can proliferate, thus favouring an effective healing process.
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( 3 / 53 )Helistat® (Absorbable Collagen Hemostatic Sponge)-Helitene® (Absorbable Collagen Hemostatic Agent - Fibrillar Form)
Integra’s hemostasis products are used in surgical procedures to help control bleeding. The company's absorbable collagen hemostatic sponge products consist of Helistat® (Absorbable Collagen Hemostatic Sponge), Helitene® (Absorbable Collagen Hemostatic Agent - Fibrillar Form), and related products. Integra's products have been manufactured for more than 20 years and are estimated to have been used in millions of patients.
Performance . . . Purity . . . Pricing . . .
Helistat and Helitene are two forms of the same pure, raw material collagen, processed from the bovine deep flexor tendon. Both are easy to use and cost effectiveness.
Performance
Active hemostatic agent
Promotes platelet aggregation
Effectively controls bleeding within 2 to 5 minutes
Does not swell in situ
Extensive history of safety and effectiveness
Helistat Sponge is not contraindicated with the use of most cell saving devices
Better Handling
Compresses into on cohesive mass
Can be fitted into smaller areas and lacerations
Readily placed with dry gloves or forceps
Helistat can be wrapped, packed, sutured or placed on a multitude of bleeding sites.
Ease of Use
Excellent adherence to bleeding site
Can be used dry or wet and can be used with saline or thrombin
Helistat is soft, non-shedding, pliable.
Does not adhere to instruments when wet
Helistat can be cut to size when dry, allowing more efficient application
Helistat is easily removed without shedding, fragmenting or causing rebleeding at wound site
Helistat when wet makes an excellent hemostatic paste
Helitene is easily irrigated from wound site
Purity
One of the purest commercially available collagen sources
Bioabsorbable
Non-pyrogenic
Does not enhance bacterial growth
Does not inhibit wound healing
Pricing
Cost effective
Packaged to fit procedural needs. Ensures less product waste
Priced to benefit your patient
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Avitene works best when applied dry: However, when this is not possible, the technique described below under "neurosurgery", or a similar technique, should be used.
Surface to be treated should first be compressed with dry gauze and then covered with Avitene. The amount required will depend on the force and severity of the bleeding. It is necessary to apply moderate pressure over the Avitene with a dry gauze.
Apply Avitene, in either the fibrous (flour) or non-woven web (sheet) forms, directly to the source of bleeding, otherwise Avitene may seal over the exit site of deeper hemorrhage and conceal an underlying hematoma.
Apply pressure with a dry sponge. In neurosurgery apply with a moist cottonoid or sponge. It is necessary to apply moderate pressure over the Avitene with dry gauze. The period of time necessary will vary with the severity of the bleeding and may range from a minute for capillary bleeding to three to five minutes for brisk bleeding or arterial leaks. For control of oozing from cancellous bone, Avitene should be firmly packed into the spongy bone surface.
Note for Neurosurgery: In the case of copious pooled blood, a piece of non-woven web may be cut to an appropriate size and placed on the surface of the pool. A moist cottonoid or sponge should then be placed over the Avitene and the pool of blood is then aspirated through the cottonoid and Avitene. This will achieve firm adhesion of the Avitene to the bleeding site.
Remove excess Avitene: After five to ten minutes, excess Avitene should be removed, either by teasing away or by irrigation with saline, followed by aspiration. If breakthrough bleeding occurs in areas of thin application, additional Avitene may be applied. The amount required will depend on the severity of the bleeding. One gram will normally treat an area of 50cm2. Thicker coverage may be required for brisk bleeding.
1 gram SyringeAvitene
One gram SyringeAvitene is an applicator that is preloaded with 1 gram of Avitene flour. It is designed to control bleeding in open surgeries, and to access deep penetrating wounds.
Follow accepted sterile technique when removing from foil pouch and introducing into sterile field.
Position the distal end of the applicator over the bleeding site.
Depress the syringe plunger to deliver Avitene to the site of application. The amount of Avitene dispensed can be controlled by the amount of pressure applied to the plunger. Avoid getting the tip of the applicator wet by ejecting a small amount beyond the tip of the applicator before applying.
Excess Avitene can be irrigated and suctioned away.
5mm SyringeAvitene
The 5mm SyringeAvitene was developed to control bleeding in hard-to-access anatomy, particularly neurosurgery, and ENT procedures. It is a 5mm diameter delivery system, preloaded with a sheet of Avitene Non-Woven Web Sheet.
Follow accepted sterile technique when removing from foil pouch and introducing into sterile field.
Position the distal end of the applicator over the bleeding site.
Depress the syringe plunger to deliver Avitene to the site of application. The amount of Avitene dispensed can be controlled by the amount of pressure applied to the plunger. Slightly twist the tip of the applicator to apply a portion of the Avitene Non-Woven Web Sheet.
The 5mm SyringeAvitene has an atraumatic tip that can be used to position the Avitene and apply pressure once the contents have been ejected.
Excess Avitene can be irrigated and suctioned away.
After use, the applicators are potentially biohazardous products due to exposure to blood and body fluids. Dispose of any potentially, biohazardous products in accordance with accepted medical practice and applicable local, state and federal regulations and the institution's written policy for the disposal of potentially biohazardous material.
EndoAvitene
EndoAvitene is designed for use in endoscopic surgery, and is available in 5mm and 10mm diameters to pass through standard size trocars and cannulae. EndoAvitene is a sterile, disposable applicator that comes preloaded with a sheet of Avitene Non-Woven Web Sheet.
Follow accepted sterile technique when removing from foil pouch and introducing into sterile field.
Position the distal end of the applicator over the bleeding site.
Depress the syringe plunger to deliver Avitene to the site of application. The amount of Avitene dispensed can be controlled by the amount of pressure applied to the plunger. Slightly twist the tip of the applicator to apply a portion of the Avitene Non-Woven Web Sheet.
EndoAvitene has an atraumatic tip that can be used to position the Avitene and apply pressure once the contents have been ejected.
Excess Avitene can be irrigated and suctioned away.
After use, the applicators are potentially biohazardous products due to exposure to blood and body fluids. Dispose of any potentially, biohazardous products in accordance with accepted medical practice and applicable local, state and federal regulations and the institution's written policy for the disposal of potentially biohazardous material.
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FLOSEAL is an effective hemostat that stops bleeding in 2 minutes or less (median time to hemostasis).
Indications
FLOSEAL is indicated in surgical procedures (other than opthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Features
Works on wet, actively bleeding tissue and conforms to irregular wound surfaces 2
Proven to control bleeding from oozing to pulsatile flow 1
Convenient kit contains all the items necessary for use, including human thrombin, and can be prepared in as short as 2 minutes
FLOSEAL can be applied focally or extruded and spread to cover a large area of diffuse bleeding*
*Please refer to Instructions For Use for complete application techniques
FLOSEAL can be applied to both hard and soft tissue 3
Safety and Efficacy
Stops bleeding in 2 minutes or less (median time to hemostasis)1
Stops bleeding 97% of the time within 6-10 minutes [per protocol analysis]1
Proven to control bleeding from oozing to pulsatile flow1
Effective 89% of the time within 10 minutes in heparinized cardiac patients 1
Important Safety Information
FLOSEAL must not be injected into blood vessels, or allowed to enter blood vessels. Do not apply in the absence of active bleeding. Extensive intravascular clotting and even death may result.
Do not use FLOSEAL in the closure of skin incisions because it may interfere with the healing of the skin edges.
Do not use FLOSEAL in patients with known allergies to materials of bovine origin.
FLOSEAL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
FLOSEAL is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.
The maximum swell volume of approximately 20% is achieved within about 10 minutes. Excess FLOSEAL (material not incorporated in the hemostatic clot) should be removed from the site of application using gentle irrigation.
FLOSEAL should not be used in conjunction with methylmethacrylate or other acrylic adhesives.
References
Floseal Hemostatic Matrix Instructions For Use, 03/2005.
Oz M.C., Cosgrove D.M., Badduke B.R., et al. Controlled Clinical Trial of a novel hemostatic agent in cardiac surgery. Ann Thoracic Surgery, 69(5): 1376-82, 2000.
Renkens Jr. K.L., et al. A Multicenter, Prospective, Randomized Trial Evaluating a New Hemostatic Agent for Spinal Surgery. Spine 2001: 26: 1645-1650.
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Surgicel is a hemostat (blood-clot-inducing material) made of cellulose, manufactured by Johnson and Johnson's Ethicon subsidiary. It is used to control post-surgical bleeding. It is also used by some boxing cutmen to control bleeding.
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