TISSEEL (fibrin sealant) Indications
Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (> 1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients.
Sealing: TISSEEL is a fibrin sealant indicated 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 directly into the circulatory system or into highly vascularized tissue. Intravascular application of TISSEEL 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 in surgery.
Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin.
Do not use TISSEEL for treatment of severe or brisk arterial or venous bleeding. In these situations, TISSEEL will be washed away in the flow of blood before hemostasis can be attained.
Do not spray TISSEEL 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. Such reactions may especially be seen if TISSEEL is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously.
Aprotonin 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 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. This can occur if a spray device is used at higher than recommended pressures and in closer than recommended proximity to the tissue surface.
When using the EASYSPRAY device, or an equivalent spray device for open surgical procedures cleared by FDA, TISSEEL must not be sprayed in enclosed body areas and must be sprayed onto only visible application sites.
TISSEEL is denatured when exposing 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.
Apply TISSEEL 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 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 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
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.
PERCLOT Absorbable Hemostatic Powder 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.
