Adjunctive Hemostats and Sealants

Floseal Hemostatic Matrix Indications and Important Risk Information 

Indications 

Floseal Matrix is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Important Risk Information

Do not inject intravascularly. 

Do not inject or compress Floseal Matrix into blood vessels. 

Do not apply Floseal Matrix in the absence of active blood flow, e.g., while the vessel is clamped or bypassed, as extensive intravascular clotting and even death may result. 

Do not administer to patients with a history of hypersensitivity to Recothrom Thrombin Topical (Recombinant), any components of Recothrom, or hamster proteins. 

Do not use Floseal Matrix in patients with known allergies to materials of bovine origin. 

Do not use Floseal Matrix in the closure of skin incisions because it may interfere with the healing of the skin edges due to mechanical interposition of gelatin. 

Floseal Matrix is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis. Floseal Matrix is not intended to be used as a prophylactic hemostatic agent. 

As with other hemostatic agents, do not apply Floseal Matrix to sites where there is negative peripheral venous pressure, as material may be drawn into the vascular system potentially resulting in life threatening thromboembolic events. 

Excess Floseal Matrix (material not incorporated in the hemostatic clot) should always be removed by gentle irrigation and suctioned out of the wound. 

The particles of Floseal Matrix swell approximately 10-20% (upon contact with blood or other fluids) and surgeons should consider its potential effect on the surrounding anatomic areas. Maximum swell volume is achieved within about 10 minutes. 

Floseal Matrix should not be used in the presence of infection. Floseal Matrix should be used with caution in contaminated areas of the body. 

The safety and effectiveness of Floseal Matrix for use in ophthalmic procedures has not been established. 

Floseal Matrix should not be used for controlling post-partum bleeding or menorrhagia. 

The safety and effectiveness of Floseal Matrix has not been established in children under 2 years of age and pregnant women. 

It is not known whether Floseal Matrix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Floseal Matrix should be administered to a pregnant woman only if clearly needed. 

Do not use air to remove residual Floseal Matrix from Applicator tip. The Applicator tips should not be cut, as tissue injury from sharp edges may result. 

Hypersensitivity reactions, including anaphylaxis, may occur. Recothrom thrombin is produced in a genetically modified Chinese Hamster Ovary (CHO) cell line and may contain hamster or snake proteins. 

For single use only. Do not re-sterilize. 

Floseal Matrix should not be applied before the application site is cleaned to remove any antiseptics that may contain alcohol, iodine, or heavy metal ions. 

When placed into cavities or closed tissue spaces, gentle approximation is advised. Do not compress. 

As with other hemostatic agents, do not aspirate Floseal Matrix into extracorporeal cardiopulmonary bypass circuits or autologous blood salvage circuits. 

Do not use Floseal Matrix on bone surfaces where adhesives, such as methylmethacrylate or other acrylic adhesives, will be required to attach a prosthetic device. 

Floseal Matrix should not be used for the primary treatment of coagulation disorders. 

The safety and effectiveness of the combined use of Floseal Matrix with antibiotic solutions or powders has not been established. 

The safety and effectiveness for use in neurosurgical and urological procedures has not been established through randomized clinical studies. 

In urological procedures, Floseal Matrix should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation. 

Antibody formation to Recothrom thrombin occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin. 

Thrombin must be added to the Gelatin Matrix prior to use. 

Rx Only. For safe and proper use of this device, refer to the full Instructions for Use. 

Instructions for Use: 

• FLOSEAL Matrix 5mL
• FLOSEAL Matrix 10mL 

Recothrom Thrombin Topical (Recombinant) Indications and Important Safety Information

RECOTHROM Thrombin Topical (Recombinant) Indication

Recothrom Thrombin Topical (Recombinant) is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. 

Recothrom Thrombin Topical (Recombinant) may be used in conjunction with an absorbable gelatin sponge, USP. 

RECOTHROM Thrombin Topical (Recombinant) Important Risk Information

Do not inject directly into the circulatory system. 

Do not use for the treatment of massive or brisk arterial bleeding. 

Do not administer to patients with a history of hypersensitivity to Recothrom Thrombin topical (Recombinant) or any components of Recothrom or hamster proteins. 

Recothrom Thrombin Topical (Recombinant) causes thrombosis if it enters the circulatory system. Apply topically. DO NOT INJECT. 

Hypersensitivity reactions, including anaphylaxis, may occur. 

The most common adverse reaction (incidence 6%) was thromboembolic events. 

Antibody formation to Recothrom Thrombin Topical (Recombinant) occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin. 

Please see accompanying full Prescribing Information for Recothrom Thrombin Topical (Recombinant). 

Tisseel (Fibrin Sealant) Indications and Important Risk Information

TISSEEL (Fibrin Sealant) Indications  

Hemostasis: Tisseel (Fibrin Sealant) is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. Tisseel (Fibrin Sealant) is effective in heparinized patients.  

Sealing: Tisseel (Fibrin Sealant) is a fibrin sealant indicated in adult and pediatric patients as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies. 

Important Risk Information for TISSEEL (Fibrin Sealant)

For Topical Use Only. Do not inject TISSEEL (Fibrin Sealant) directly into the circulatory system or into highly vascularized tissue, such as nasal mucosa. Intravascular application of TISSEEL (Fibrin Sealant) can lead to intravascular coagulation, can result in life-threatening thromboembolic events, and can increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients. To minimize the risk of intravascular application, exercise caution when using Tisseel (Fibrin Sealant) in surgery.  

Do not use Tisseel (Fibrin Sealant) in individuals with a known hypersensitivity to aprotinin.  

Do not use Tisseel (Fibrin Sealant) for treatment of severe or brisk arterial or venous bleeding. In these situations, Tisseel (Fibrin Sealant) will be washed away in the flow of blood before hemostasis can be attained.  

Do not spray Tisseel (Fibrin Sealant) where the minimum recommended distance from the applicator tip to the target site cannot be assured.  

Hypersensitivity or allergic/anaphylactoid reactions can occur with the use of Tisseel (Fibrin Sealant). Such reactions may especially be seen if Tisseel (Fibrin Sealant) is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously.  

Aprotinin is known to be associated with anaphylactic reactions. Even in the case of strict local application of aprotinin, there is a risk of anaphylactic reactions to aprotinin, particularly in the case of previous exposure.  

Discontinue administration of Tisseel (Fibrin Sealant) in the event of hypersensitivity reactions. Remove remaining product from the application site  

Air or gas embolism has occurred when fibrin sealant was administered using pressurized gas with open regulator spray devices. This can occur if a spray device is used at higher than recommended pressures and in closer than recommended proximity to the tissue surface.  

Monitor changes in blood pressure, pulse, oxygen saturation and end tidal CO₂ due to the possibility of air or gas embolism.  

When using the Easyspray device, or an equivalent spray device for open surgical procedures cleared by FDA, Tisseel (Fibrin Sealant) must not be sprayed in enclosed body areas and must be sprayed onto only visible application sites.  

Tisseel (Fibrin Sealant) may be denatured when exposed to solutions containing alcohol, iodine or heavy metals. If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of Tisseel (Fibrin Sealant).  

Apply Tisseel (Fibrin Sealant) as a thin layer by dripping or spraying using cannula or spray set. Excess clot thickness can negatively interfere with wound healing.  

The safety and effectiveness of Tisseel (Fibrin Sealant) used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated; its use in this setting is not FDA approved.  

Tisseel (Fibrin Sealant) is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt- Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.  

Please see accompanying full Prescribing Information for Tisseel (Fibrin Sealant). 

PerClot Absorbable Hemostatic Powder Indications and Important Risk Information

Indications

PerClot Absorbable Hemostatic Powder is indicated in surgical procedures (except neurological and ophthalmic) as an adjunctive hemostatic device to assist when control of suture line bleeding or capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures are ineffective or impractical.

Important Risk Information

Do not inject or place PerClot into blood vessels such as artery or vein as potential for embolization and death may exist. 

Do not use PerClot for treatment of severe or extreme bleeding. 

Do not inject into bladder or ureteral lumen. 

Single use only. Do not re-use. Do not re-sterilize. Re-use or reprocessing of a single use device may lead to contamination and compromised device function or structural integrity. 

Safety and efficacy of PerClot have not been clinically evaluated in children (less than 21 years old) and pregnant or lactating women. 

PerClot should be used with caution in the presence of infection or in contaminated areas of the body. If signs of infection or abscess develop where PerClot has been applied, re-operation may be necessary in order to allow drainage. 

Safety and efficacy of PerClot in neurological and ophthalmic procedures have not been established. 

Safety and efficacy of PerClot have not been clinically evaluated for use in controlling post-partum bleeding or menorrhagia. 

Once hemostasis is achieved, excess PerClot should be removed from the site of application by irrigation and aspiration particularly when used in the pericardial cavity and around foramina of bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm. PerClot achieves its maximum swelling within 10 minutes when exposed to blood or other fluids. Dry, white PerClot should be removed. The possibility of the product interfering with normal function and/or causing compression of surrounding tissues due to swelling is reduced by removal of excess dry material. 

The effect of this product on patients with known sensitivity to starch or starch-derived materials has not been studied. 

The efficacy of PerClot in achieving hemostasis in cortical bone and spinal bleeding has not been studied in randomized clinical trials. 

Blood vessels, suture line gaps, and large needle holes with a diameter of ≥2mm must be ligated prior to PerClot application. 

Do not apply more than 50g of PerClot in diabetic patients as it has been calculated that amounts in excess of 50g could affect the glucose load. 

As with other hemostatic agents, do not apply PerClot to sites where there is negative peripheral venous pressure as material may be drawn into the vascular system potentially resulting in life-threatening thromboembolic events. 

Rx Only. For safe and proper use please refer to full device Instructions for Use for Contraindications, Warnings and Precautions. 

PerClot Absorbable Hemostatic Powder IFU 

Coseal Surgical Sealant Indications and Important Risk Information

Coseal Surgical Sealant Indications

Coseal Surgical Sealant is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

Important Risk Information for Coseal Surgical Sealant

Coseal Surgical Sealant is not to be used in place of sutures, staples, or mechanical closure. 

Coseal Surgical Sealant swells up to four times its volume within 24 hours of application and additional swelling occurs as the gel resorbs. Therefore, surgeons should consider the maximum swell volume and its possible effect on surrounding anatomic structures potentially sensitive to compression. 

Apply only as a thin layer. 

Use caution when applying with pressurized gas. 

Do not place devices or other objects on top of tissue where Coseal Surgical Sealant has been applied, until the material is fully polymerized (non-tacky). Allow at least 60 seconds after application, and before touching or laying any object on top of the Coseal Surgical Sealant.

Do not apply Coseal Surgical Sealant over any devices or objects that will need to be removed. Coseal Surgical Sealant must not be used as a mechanism of adherence, even temporarily, for any object. 

Do not inject Coseal Surgical Sealant into vessels. 

The safety and performance of Coseal Surgical Sealant have not been established in children and pregnant women.

In vivo testing demonstrated a mild skin sensitization response in an animal model. Similar testing in humans has not been conducted. 

Rx only: For safe and proper use of this device, please refer to full device Instructions for Use. 

Coseal Surgical Sealant Full Instructions for Use

Preveleak Surgical Sealant Indications and Important Risk Information

PREVELEAK Surgical Sealant Indication 

Preveleak Surgical Sealant is indicated for use in vascular and cardiac reconstructions (excluding application to arterial and venous grafts used in coronary artery bypass graft surgery) to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage. 

PREVELEAK Surgical Sealant Contraindications 

Not for use in patients with known allergies to materials of bovine or shellfish origin. 

Not for intravascular use. 

Not for cerebrovascular repair or cerebrospinal leak repair. 

PREVELEAK Surgical Sealant Important Risk Information 

Do not use as a substitute for sutures or staples. 

Open lumen procedures require protection of the lumen. 

Avoid exposure to nerves including the sinoatrial node, and the atrial ventricular nodes. 

Do not use in the presence of obvious infection and use with caution in contaminated areas of the body. 

Do not allow either the uncured or polymerized form to come into contact with circulating blood. 

Preveleak Surgical Sealant contains a material of animal origin that may be capable of transmitting infectious agents. 

Repeated use of Preveleak Surgical Sealant in subsequent surgeries has not been studied. Hypersensitivity reactions were not seen using Preveleak Surgical Sealant, but hypersensitivity of BSA has been reported. 

Avoid tissue contact with material expelled from delivery tip during priming. 

Avoid contact with skin or other tissue not intended for application. 

Do not use blood saving devices when suctioning excess Preveleak Surgical Sealant from the surgical field. 

Avoid pausing more than 10-15 seconds between priming and application to prevent polymerization within the delivery tip. 

Minimize use in patients with abnormal calcium metabolism (e.g. chronic renal failure, hyperparathyroidism). 

Safety and effectiveness of Preveleak Surgical Sealant in minimally invasive procedures have not been established. 

Polyaldehyde treated tissue can have an enhanced propensity for mineralization. 

Evidence of cytotoxicity was observed during cell culture-based laboratory assays and is believed to be due to the polyaldehyde component of the product. No evidence of cytotoxicity was observed in animal or clinical studies. 

Do not use Preveleak Surgical Sealant on arterial or venous grafts during coronary artery bypass graft surgery. Preveleak Surgical Sealant may reduce the vasoreactivity of vascular (i.e. internal mammary artery, radial artery or saphenous vein) grafts used in coronary artery bypass graft surgery at the site of application. 

PREVELEAK Surgical Sealant Use in Specific Populations 

Use of Preveleak Surgical Sealant in pediatric or pregnant patients has not been studied. 

Rx only. For safe and proper use of this device, please refer to the full Instructions for Use.

Artiss [Fibrin Sealant (Human)] Indications and Important Risk Information

ARTISS [Fibrin Sealant (Human)] Indications

Artiss [Fibrin Sealant (Human)] is a fibrin sealant indicated in adult and pediatric patients to:

• Adhere autologous skin grafts to surgically prepared wound beds resulting from burns 
• Adhere tissue flaps during facial rhytidectomy surgery 

Limitations of Use

Artiss [Fibrin Sealant (Human)] is not indicated as an adjunct to hemostasis

Important Risk Information for ARTISS [Fibrin Sealant (Human)]           

• For Topical Use Only. Do not inject directly into the circulatory system or into highly vascularized tissue. Intravascular application can result in life-threatening thromboembolic events and can increase the likelihood and severity of acute hypersensitivity reaction in susceptible patients.
• Do not use in individuals with a known hypersensitivity to aprotinin and/or hypersensitivity to any of the active substances or excipients of Artiss [Fibrin Sealant (Human)].
• Do not spray where the minimum recommended distance from the applicator tip to the target site cannot be assured.
• Hypersensitivity reactions, including anaphylaxis, can occur. Should symptoms occur, discontinue and administer appropriate treatment. Such reactions may especially be seen if product is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously; however, these reactions may also occur in patients receiving Artiss [Fibrin Sealant (Human)] for the first time.
• Aprotinin is known to be associated with anaphylactic reactions. Even in the case of strict local application of aprotinin, there is a risk of anaphylactic reactions to aprotinin, particularly in the case of previous exposure.
• Discontinue administration in the event of hypersensitivity reactions. Remove the already applied, polymerized product from the surgical field.
• Life threatening/fatal air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. This can occur if a spray device is used at higher than recommended pressures and in closer than recommended proximity to the tissue surface. To reduce the risk of potential life-threatening gas embolism, spray using only the appropriate pressurized gas at the recommended pressure (21.8-29.0 psi) and distance (10-15 cm). Use the Easyspray device, or an equivalent spray device cleared by FDA, connected to a medical grade CO₂, Compressed Air or Nitrogen. The risk appears to be higher when fibrin sealants are sprayed with air, as compared to CO₂. Spray only onto visible application sites, not in enclosed body cavities.
• Artiss [Fibrin Sealant (Human)] may denature when exposed to solutions containing alcohol, iodine or heavy metals. If these substances have been used to clean the wound area, the area should be thoroughly rinsed and dried before application of Artiss [Fibrin Sealant (Human)].
• Artiss [Fibrin Sealant (Human)] is made from human plasma, it may carry the risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the classic Creutzfeldt-Jakob disease agent.
• Most common adverse reactions reported in ≥ 1% of clinical trial subjects with the use of Artiss [Fibrin Sealant (Human)] were: Skin graft failure, hematoma and pruritus in burn studies, and hematoma/seroma in rhytidectomy studies.

Please see accompanying full Prescribing Information for Artiss [Fibrin Sealant (Human)].

Ostene Bone Hemostasis Material Indications and Important Risk Information

OSTENE[Bone Hemostasis Material] Indications for Use 

Ostene Bone Hemostasis Material is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces. Ostene Bone Hemostasis should be warmed to desired consistency using aseptic techniques.

OSTENE Bone Hemostasis Material Important Risk Information

Do not use Ostene Bone Hemostasis Material in sites with active or latent infections. Ostene Bone Hemostasis Material is not intended for use in lending structural support to bone.

Ostene Bone Hemostasis Material is provided sterile for single use only. DO NOT RESTERILIZE. Discard any open, unused, or damaged packages. DO NOT USE if there is a loss of sterility of the device. Ostene Bone Hemostasis Material should not be subjected to excess heat. Store at room temperature away from direct heat, including sunlight.

Rx Only: For safe and proper use of this device please refer to full device instructions for use.

Ostene Bone Hemostasis Material Full Instructions for Use