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FloSeal Hemostatic Matrix


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									                                                                Warnings:                                                   FloSeal Matrix Adverse Events:                               Equivalence of Bovine and Human Thrombin:                   Time to Hemostasis
FloSeal Hemostatic Matrix                                        • FloSeal Matrix contains Thrombin made from               In a randomized prospective, concurrently controlled         The performance of FloSeal Matrix containing human
                                                                                                                                                                                                                                                     First Lesion Only (Protocol Valid Lesions)

Instructions for Use                                               human plasma. Products made from human                   clinical trial using a formulation of FloSeal Matrix con-    thrombin was compared to that of original FloSeal (con-                                Median Time to
                                                                   plasma may contain infectious agents, such as            taining bovine thrombin, (FloSeal), a total of 309           taining bovine thrombin) in a bleeding liver square                                    Hemostasis in minutes
Caution: Federal Law restricts this device to sale by or                                                                                                                                                                                                                        (95% Confidence Interval*)
                                                                   viruses, that can cause disease. The risk that such      patients received FloSeal or the Control (Gelatin            model in pigs.
on the order of a physician (or properly licensed practi-
                                                                   products will transmit an infectious agent has           Sponge + Thrombin). The most common adverse events           Blood flow rates for the lesions created in the pig liver   Patient Category          FloSeal            Control
                                                                   been reduced by screening plasma donors for prior        recorded during and after the application of the hemo-       model were recorded at specific time points and sta-
DO NOT INJECT.                                                     exposure to certain viruses, by testing for the          static agents were anemia, atrial fibrillation, infection,                                                               All Patients              2.0 (1.5, 2.5)   6.0 (5.5, 6.0)
                                                                                                                                                                                         tisitically analyzed by the method of Blackwelder and
FloSeal Hemostatic Matrix (“FloSeal Matrix”) must not              presence of certain current virus infections, and by     and hemorrhage. The following is a complete list of          Chang modified for continuous variables. This analysis      Cardiac                   2.8 (2.0, 4.0)   8.0 (6.0, 8.5)
be injected into blood vessels.                                    inactivating and removing certain viruses. Despite       adverse events reported in greater than 1% of patients       demonstrates that the performance of FloSeal Matrix is      Vascular                  2.5 (2.0, 4.0)   6.5 (4.5, 8.0)
                                                                   these measures, such products can still potentially      that were observed in the pivotal clinical trial for the     equivalent to the performance of FloSeal with a p-value
Device Description:                                                                                                                                                                                                                                  Spinal/Orthopedic         1.5 (1.0, 1.5)   3.0 (2.0, 4.5)
                                                                   transmit disease. Because this product is made           FloSeal group. The corresponding adverse events for          of < 0.001 at each of the time intervals.
FloSeal Matrix consists of a bovine-derived Gelatin                from human blood, it may carry a risk of                 the Control group are listed for comparison. None of
                                                                                                                                                                                         In addition, each lesion was subjectively scored for        *Confidence interval using a Bonferroni correction.
Matrix component, a human-derived Thrombin compo-                  transmitting infectious agents, e.g., viruses, and       the adverse events that occurred were judged by the
nent, applicator tips, and several mixing accessories.             theoretically, the Creutzfeldt-Jakob disease (CJD)       surgeon to be “Probably Related” to the use of FloSeal.      bleeding at each time point. These data were analyzed
                                                                                                                                                                                                                                                     Use of FloSeal as a Hemostatic Agent
The mixing accessories include a syringe with an integral          agent. ALL infections thought by a physician                                                                          using the method of Blackwelder and Chang for propor-
                                                                                                                                                                                                                                                     for Nasal/Sinus Bleeding:
female Luer connector, a small bowl, and a 5 mL syringe            possibly to have been transmitted by this product                                                                     tions. The results for all lesions in all animals showed
                                                                                                                            Adverse Events Reported in Greater than 1% of                FloSeal Matrix and FloSeal were equivalent for each of      FloSeal has been used as a hemostatic agent for the
with needle attached. The mixing accessories are                   should be reported by the physician or other
                                                                                                                            Patients in the FloSeal Clinical Trial Patients              the time intervals with a p-value of 0.015.                 control of operative and post-operative bleeding (epis-
included to facilitate the reconstitution and mixing of the        healthcare provider to Baxter Healthcare                                                                                                                                          taxis) during nasal/sinus surgery in 18 patients (30
Thrombin into the Gelatin Matrix. Applicator tips are              Corporation. The physician should discuss the risks
                                                                                                                                                                       Control           Clinical Studies:                                           application sites). Patients were followed for 24 hours
included to facilitate the delivery of FloSeal Matrix to the       and benefits of this product with the patient.
                                                                                                                            Adverse Event          FloSeal         (Gelatin Sponge                                                                   following surgery and all complications and episodes of
site to be treated. (For specific package contents, see                                                                                                              + Thrombin)         Study Design and Objectives: A prospective, ran-
                                                                 • FloSeal Matrix is not intended as a substitute for                                                                                                                                epistaxis were recorded during this period.
Table in “How Supplied” section.)                                                                                                                                                        domized, controlled, multi-center, multi-specialty study
                                                                   meticulous surgical technique and the proper                                                                                                                                      Intraoperative bleeding stopped in 30 of 30 (100%)
                                                                   application of ligatures or other conventional           Anemia                  12 (8%)              7 (4%)          was conducted using a formulation of FloSeal Matrix         application sites. No intraoperative complications were
The Gelatin Matrix consists of crosslinked gelatin gran-
                                                                   procedures for hemostasis. FloSeal Matrix is                                                                          containing bovine thrombin, (FloSeal). Three hundred        reported in this group. One patient presented with
ules and is provided sterile and non-pyrogenic in a                                                                         Fibrillation Atrial     10 (6%)              8 (5%)
                                                                   effective on surgical bleeding, from oozing to                                                                        and nine (309) patients were enrolled at 10 centers.        epistaxis 6 hours postoperatively; this patient was
standard disposable syringe. The Thrombin (Human) is                                                                        Infection               10 (6%)             11 (7%)
                                                                   spurting, and is not intended to be used as a                                                                         The objective of the study was to evaluate the safety       treated uneventfully and released from the hospital on
a sterile, non-pyrogenic, freeze-dried, vapor-heated
                                                                   prophylactic hemostatic agent.                           Hemorrhage               6 (4%)              6 (4%)          and effectiveness of FloSeal, compared to a commer-         the first postoperative day.
powder preparation made from pooled human plasma.
                                                                                                                                                                                         cially available control hemostat, Absorbable Gelatin
The Calcium Chloride Solution is a sterile, non-pyro-            • FloSeal Matrix should not be used in the presence        Pneumonia                6 (4%)              2 (1%)
                                                                                                                                                                                         Sponge, USP (“Gelatin Sponge”) + Thrombin, in control-      How Supplied:
genic solution. After reconstitution of the lyophilized            of infection. FloSeal Matrix should be used with         Urinary Tract Infection 6 (4%)               3 (2%)          ling intraoperative bleeding. This study was designed
Thrombin in Calcium Chloride Solution, the resulting               caution in contaminated areas of the body. If                                                                                                                                     FloSeal Matrix is provided in the configuration shown
                                                                                                                            Rash                     5 (3%)              3 (2%)          to show that the FloSeal success rate was equivalent
thrombin solution contains 500 I.U./mL Thrombin                    signs of infection or abscess develop where                                                                                                                                       in the table below.
                                                                                                                                                                                         to the success rate for the Control. Patients undergoing
(Human).                                                           FloSeal Matrix has been applied, reoperation may         Edema                    5 (3%)              1 (<1%)
                                                                                                                                                                                         surgery in cardiac, vascular or spinal/orthopedic surgi-
                                                                   be necessary in order to remove the infected             Hypotension              4 (3%)              2 (1%)          cal specialties were included.
Source Plasma obtained from US licensed plasma col-
                                                                   material and allow drainage.
lection centers is used to produce FEIBA bulk powder,                                                                       Respiratory Distress     4 (3%)              3 (2%)                                                                      FloSeal Hemostatic Matrix Configuration
                                                                 • Regardless of the type of surgical procedure,                                                                         Patients were randomized only after it was determined
the starting material of Thrombin. (Final product, FEIBA                                                                    Confusion                4 (3%)              0 (0%)                                                                      Gelatin Matrix                 Thrombin Component
                                                                   surgeons should consider the maximum swell                                                                            that the bleeding could not be controlled using conven-
VH Anti-Inhibitor Coagulant Complex, which is manu-                                                                                                                                                                                                  Component
                                                                   volume of approximately 20% of FloSeal Matrix            Dural Tear               4 (3%)              4 (3%)          tional approaches (e.g. direct pressure, sutures and/or
factured by Baxter Healthcare Corporation from the                                                                                                                                                                                                   • 1 x 5 mL syringe
                                                                   after product is applied and its potential effect on                                                                  cautery) because of their ineffectiveness or impractical-                                 • 1 x vial Thrombin
same bulk, is licensed and distributed in the US for the                                                                    Fibrillation Ventricular 4 (3%)              3 (2%)
                                                                                                                                                                                         ity. Success at achieving hemostasis was defined as           with Gelatin Matrix           (Human) containing:
control of spontaneous bleeding episodes or to cover               the surrounding anatomic areas. Maximum swell
                                                                                                                            Arrhythmia               4 (3%)              0 (0%)          cessation of bleeding within 10 minutes following
surgical interventions in hemophilia A and B patients              volume is achieved within about 10 minutes.                                                                                                                                       • 1 x 5 mL syringe with            • 2500 IU thrombin
                                                                                                                            Heart Failure Right      3 (2%)              2 (1%)          application of the agent. The primary endpoint was            integral female Luer
with inhibitors.) Thrombin is prepared by dissolving              • Excess FloSeal Matrix (material not incorporated                                                                                                                                                                    • 225-275 mg total
                                                                                                                                                                                         hemostasis success for the first treated bleeding site. A     connector
FEIBA bulk powder and incubating the solution with                  in the hemostatic clot) should be removed by            Thrombosis Arterial      3 (2%)              8 (5%)
                                                                                                                                                                                         secondary endpoint was time to hemostasis for the first                                          protein
calcium chloride in order to activate prothromin to                 gentle irrigation from the site of application,         Fever                    3 (2%)              2 (1%)                                                                      • 1 x bowl for Thrombin
                                                                                                                                                                                         treated bleeding site. Although multiple bleeding sites                                        • 40-60 mg sodium
thrombin. After several filtration steps, the final bulk            particularly when used in, around, or in proximity                                                                                                                               • Applicator tips (2)
                                                                                                                            Atelectasis              3 (2%)              1 (<1%)         in the same patient were treated, only the first treated                                          chloride
solution is freeze-dried. The Calcium Chloride Solution             to foramina in bone, areas of bony confine, the                                                                      bleeding site was used to determine primary effective-
is prepared from calcium chloride complying with the                spinal cord, and/or the optic nerve and chiasm.         Pleural Effusion          3 (2%)              5 (3%)                                                                                                        • 12-18 mg glycine
                                                                                                                                                                                         ness, as this was the only site that was truly random-
specifications listed in the US Pharmacopeia.                                                                               Counts reflect number of patients in each treatment                                                                                                    • 1 x vial Calcium Chloride
                                                                 • The safety and effectiveness of FloSeal Matrix for                                                                    ized.
                                                                   use in ophthalmic procedures has not been                group reporting one or more adverse events that map to                                                                                                   Solution, 5 mL
Thrombin is made from pooled human plasma. The
                                                                   established.                                             a Modified COSTART 5 th edition body system. At each         Clinical Study Results:
two-step vapor heat treatment used in its manufacture                                                                                                                                                                                                                                   • 200 mol CaCl2
                                                                                                                            level of summarization (Adverse Event), patients are
has been shown to be capable of significant viral                • FloSeal Matrix should not be used for controlling                                                                     Primary Endpoint: The primary endpoint, cessation of                                      • 1 x 5 mL syringe with
                                                                                                                            only counted once.
reduction. However, no procedure has been shown to                 post-partum bleeding or menorrhagia.                                                                                  bleeding within 10 minutes of the first lesion, achieved                                    needle attached
be completely effective in removing viral infectivity                                                                                                                                    a success rate of 96% in the FloSeal group and 77% in
                                                                 • The safety and effectiveness of FloSeal Matrix has
from derivatives of human plasma (see Warnings).                                                                            Other adverse events observed in 1% or less of the           the Control group. Treatment and Control were shown
                                                                   not been established in children and pregnant
                                                                   women.                                                   FloSeal clinical trial patients were myocardial infarc-      to be equivalent using the Blackwelder and Chang test,      The package also includes this FloSeal Hemostatic
The manufacturing procedure for FloSeal Matrix
                                                                                                                            tion, cellulitis, pneumothorax, pain, cerebrovascular        using a (clinically significant difference) of 0.15         Matrix Instructions for Use.
includes processing steps designed to reduce the risk
                                                                Precautions:                                                accident, hallucination, paresthesia, bradycardia,           (p<0.0001). The difference between Treatment and
of viral transmission. Several steps are included in the
                                                                                                                            abscess, diarrhea, urinary retention, dehiscence, skin       Control was also shown to be statistically significant
manufacture of the Gelatin Matrix component that
                                                                General                                                     ulcer, transfusion reaction, dyspnea, heart arrest, lung     using the Cochran-Mantel-Haenszel test (p<0.001).
reduce the risk of viral transmission. The virus reduc-
                                                                                                                            edema, back pain, ventricular tachycardia, neuropathy,
tion factors (expressed as log10) for the manufacture of         • For single use only. Do not resterilize.                                                                              Primary endpoint data were stratified for individual sur-
                                                                                                                            acute kidney failure, kidney tubule necrosis, gastritis,
the Gelatin Matrix component are provided in the table                                                                                                                                   gical specialties, and the results are summarized in the
                                                                 • Since the Thrombin Solution can be denatured by          nausea, nausea and vomiting, skin rash, hyperglycemia,
below.                                                                                                                                                                                   table below:
                                                                   contact with solutions containing alcohol, iodine,       and heel ulcer.
Reduction Factors for Virus Removal and/or                         or heavy metal ions, FloSeal Matrix should not be                                                                     Hemostasis within 10 minutes – First Lesion Only
                                                                                                                            The following adverse events, all rated “mild”, were
Inactivation during the Manufacture of Gelatin                     applied before the application site is cleaned to                                                                     (Intent-to-Treat Patients)
                                                                                                                            deemed by the surgeon to be “Possibly Related” to the
Matrix                                                             remove any antiseptics that may contain such
                                                                                                                            use of FloSeal: anemia (2 patients, 1%), mild post-oper-     Patient Category         FloSeal             Control
                                Virus Reduction Factor                                                                      ative bleeding (1 patient, <1%), and local inflammation
                                of Virus Tested                  • When placed into cavities or closed tissue spaces,                                                                    All Patients          96% (149/156)      77% (118/153)
                                                                                                                            (1 patient, <1%). No other adverse events were
Manufacturing Step              BVDV             PPV               gentle approximation is advised. When applied to         deemed by the surgeon to be related to the use of            Cardiac               94% (45/48)         60% (27/45)
                                                                   a bleeding site, the particles of FloSeal Matrix         FloSeal.                                                     Vascular              93% (40/43)         76% (35/46)
Base Treatment (NaOH)           >5.42            3.99              swell approximately 20% upon contact with blood
                                                                                                                            Allergic reactions may be encountered in people known        Spinal/Orthopedic     98% (64/65)         90% (56/62)
                                                                   or other fluids. Maximum swell volume is
Chemical Cross-linking          >4.96            1.06                                                                       to be sensitive to bovine materials.
                                                                   achieved within about 10 minutes.
Heat Treatment                  >6.46            1.87                                                                                                                                    In the cardiac cohort, 88 of the 93 patients (95%)
                                                                 • As with other hemostatic agents, do not aspirate         Gelatin-Based Hemostatic Agents:
                                                                                                                                                                                         underwent surgery with extracorporeal cardiopulmonary
                                                                   FloSeal Matrix into extracorporeal                       Reported Adverse Events:
                                                                                                                                                                                         bypass. FloSeal was used for hemostasis prior to
                                                                   cardiopulmonary bypass circuits or autologous
A two-step vapor heating process is included in the                                                                          • Gelatin-based hemostatic agents may serve as a            heparin reversal by the administration of protamine sul-
                                                                   blood salvage circuits. It has been demonstrated
manufacture of Thrombin. The virus reduction factors                                                                           nidus for infection and abscess formation and             fate in 19 of 46 patients. Protamine sulfate reverses
                                                                   that fragments of collagen based hemostatic
(expressed as log10 ) for Thrombin are provided in the                                                                         have been reported to potentiate bacterial growth.        the anticoagulative effects of heparin. Results for
                                                                   agents may pass through 40 transfusion filters
table below.                                                                                                                 • Giant cell granulomas have been observed at               hemostasis at 10 minutes for the heparinized patients
                                                                   of blood scavenging systems.
                                                                                                                               implant sites when used in the brain.                     in both the FloSeal and Control groups, before and after
                                                                 • FloSeal Matrix should not be used in conjunction                                                                      protamine sulfate reversal of heparin, are shown in the
Reduction Factors for Virus Removal and/or                         with methylmethacrylate or other acrylic                  • Compression of the brain and spinal cord resulting
Inactivation during the Manufacture of                                                                                                                                                   table below:
                                                                   adhesives. Microfibrillar collagen has been                 from the accumulation of sterile fluid has been
Thrombin (Human)
                                                                   reported to reduce the strength of                          observed.
                                                                                                                                                                                         Hemostasis Success at 10 Minutes Before and
Manufacturing Step              Virus Reduction                    methylmethacrylate adhesives used to attach               • Multiple neurologic events were reported when
                                Factor of Virus Tested                                                                                                                                   After Protamine Administration
                                                                   prosthetic devices to bone surfaces.                        absorbable gelatin-based hemostatic agents were
                                                                                                                                                                                         (Cardiac Patients Only)
                       HIV-1 TBEV PRV ERV-1 HAV                  • FloSeal Matrix should not be used for the primary           used in laminectomy operations, including cauda
                                                                                                                               equina syndrome, spinal stenosis, meningitis,             Group            Before Protamine      After Protamine
Cryoprecipitation        1.4 ≤ 1.0 1.1 ≤ 1.0             n.d.      treatment of coagulation disorders.
                                                                                                                               arachnoiditis, headaches, paresthesias, pain,             FloSeal           89% (17/19)           96% (26/27)
Adsorption on                                                    • The safety and effectiveness of the combined use
                                                                                                                               bladder and bowel dysfunction, and impotence.
DEAE-Sephadex            2.0      3.0 3.1 ≤ 1.0         n.d.       of FloSeal Matrix with antibiotic solutions or                                                                        Control           36% (5/14)            75% (21/28)
                                                                   powders has not been established.                         • The use of absorbable gelatin-based hemostatic
Freeze-Drying            2.0 ≤ 1.0      2.6 1.9         2.7                                                                    agents during the repair of dural defects
                                                                 • The safety and effectiveness for use in                                                                               The success rate for FloSeal did not appear to be
Vapor Heating          >4.6     >7.0 >4.8     >4.7 >3.9                                                                        associated with laminectomy and craniotomy
                                                                   neurosurgical and urological procedures has not                                                                       affected by whether or not the patient had received
n. d. = not determined                                                                                                         operations, has been associated with fever,
                                                                   been established through randomized clinical                                                                          protamine sulfate administration. This was demon-
                                                                                                                               infection, leg paresthesias, neck and back pain,
FloSeal Matrix is the combination of the Gelatin Matrix            study.                                                                                                                strated by the fact that the success rate for FloSeal
                                                                                                                               bladder and bowel incontinence, cauda equina
component and the reconstituted Thrombin (Human)                 • In urological procedures, FloSeal Matrix should not         syndrome, neurogenic bladder, impotence, and              before protamine sulfate administration was similar to
component. Thrombin must be added to the Gelatin                   be left in the renal pelvis or ureters to eliminate         paresis.                                                  the success rate after protamine sulfate administration
Matrix component prior to use. FloSeal Matrix is bio-              the potential foci for calculus formation.                                                                            whereas the Control hemostat success rate was clearly
compatible and resorbed within 6 to 8 weeks, consis-                                                                         • The use of absorbable gelatin-based hemostatic
                                                                                                                                                                                         lower before protamine sulfate reversal of heparin was
tent with normal wound healing. FloSeal Matrix is                                                                              agents has been associated with paralysis, due to
                                                                Information for Patients                                                                                                 administered.
intended only for topical administration.                                                                                      device migration into foramina in the bone around
                                                                 • Some viruses, such as parvovirus B 19, are                  the spinal cord, and blindness, due to device             Secondary Endpoint: A secondary endpoint was time
Indications:                                                       particularly difficult to remove or inactivate at this      migration in the orbit of the eye, during lobectomy,      to hemostasis for the first treated bleeding site. The
                                                                   time. Parvovirus B 19 most seriously affects                laminectomy and repair of a frontal skull fracture        data for time to hemostasis are summarized in the
FloSeal Matrix is indicated in surgical procedures (other
                                                                   pregnant women, or immune-compromised                       and lacerated lobe.                                       table below.
than in ophthalmic) as an adjunct to hemostasis when
                                                                   individuals. Symptoms of parvovirus B 19
control of bleeding by ligature or conventional proce-                                                                       • Foreign body reactions, “encapsulation” of fluid,
                                                                   infection include fever, drowsiness, chills, and
dures is ineffective or impractical.                                                                                           and hematoma have been observed at implant                Cumulative Percent of Patients with Complete
                                                                   runny nose followed about two weeks later by a
                                                                                                                               sites.                                                    Hemostasis First Lesion (Protocol Valid Patients*)
                                                                   rash, and joint pain. Patients should be
Contraindications:                                                                                                           • Excessive fibrosis and prolonged fixation of a
                                                                   encouraged to consult their physician if such                                                                         Time Interval           FloSeal             Control
 • Do not inject or compress FloSeal Matrix into                   symptoms appear.                                            tendon have been reported when absorbable
                                                                                                                                                                                         0 – 1 minute         41% (62/153)        21% (32/150)
   blood vessels. Do not apply FloSeal Matrix in the                                                                           gelatin-based sponges were used in severed
   absence of active blood flow, eg., to clamped or                                                                            tendon repair.                                            1 – 2 minutes        69% (106/153)       32% (48/150)
                                                                Carcinogenesis, Mutagenesis, Impairment of Fertility
   bypassed vessels. Extensive intravascular clotting                                                                        • Toxic shock syndrome was reported in association          2 – 3 minutes        85% (130/153)       48% (72/150)
                                                                 • Long-term animal studies to evaluate the
   and even death may result.                                                                                                  with the use of absorbable gelatin-based
                                                                   carcinogenic potential of FloSeal Matrix or studies                                                                   3 – 6 minutes        93% (143/153)       68%(102/150)
 • To avoid a risk of allergic-anaphylactoid reaction              to determine the effect of FloSeal Matrix on                hemostats in nasal surgery.
                                                                                                                                                                                         6 – 10 minutes       97% (149/153)       77% (115/150)
   and/or thromboembolic events, which may be life-                fertility have not been performed.                        • Fever, failure of absorption, and hearing loss have
   threatening, do not inject FloSeal Matrix into a                                                                                                                                      *Six (6) patients, 3 in the FloSeal group and 3 in the
                                                                                                                               been observed when absorbable hemostatic
   vessel or tissue.                                                                                                                                                                     Control group, were excluded because of protocol devi-
                                                                Pregnancy Category C                                           agents were used during tympanoplasty.
                                                                                                                                                                                         ations in measuring hemostasis for the first treated
 • Do not use FloSeal Matrix in the closure of skin              • It is not known whether FloSeal Matrix can cause
                                                                                                                            Adverse Reactions to Human Thrombin:                         bleeding site.
   incisions because it may interfere with the healing             fetal harm when administered to a pregnant
   of the skin edges due to mechanical interposition               woman or can affect reproduction capacity.               As with any other plasma derivatives, anaphylactoid or
   of gelatin.                                                     FloSeal Matrix should be administered to a               anaphylactic reactions may occur in rare cases. No           When the data were stratified by surgical specialty, the
 • Do not use FloSeal Matrix in patients with known                pregnant woman only if clearly needed.                   adverse events of this type were reported during the         median times to hemostasis were shorter for the
   allergies to materials of bovine origin.                                                                                 course of clinical trials using a different product con-     FloSeal group than for the Control group in all special-
                                                                                                                            taining the same human thrombin component. Mild              ties. The median times are summarized in the table
                                                                                                                            reactions can be managed with antihistamines; severe         below.
                                                                                                                            hypotensive reactions require immediate intervention
                                                                                                                            using current principles of shock therapy.
Directions for Use:                                           • To minimize disruption of the clot, remove gauze
                                                                sponges after hemostasis has been achieved. If
Thrombin must be added to the Gelatin Matrix prior to use.      the gauze sponge adheres to the newly-formed
FloSeal Matrix Preparation:                                     clot, irrigate the sponge with non-heparinized
                                                                saline and carefully remove it from the treated
Inspect the integrity of the contents of the FloSeal            site.
Matrix package. If the packaging or vials have been            • In cases of persistent bleeding, indicated by
damaged or opened, do not use.                                   saturation and bleeding through the granules,
Opening the Package                                              insert the Applicator tip through the center of the
                                                                 mass of previously placed FloSeal Matrix to
 • Open the Thrombin Component package outside                   deliver fresh FloSeal Matrix as close as possible
   the sterile field. Items in this package will be              to the tissue surface. After re-application of
   used to reconstitute the Thrombin prior to                    FloSeal Matrix, resume approximation with a
   transferring it to the sterile field.                         gauze sponge for up to another two minutes, and
 • Open the outer package containing the Gelatin                 then inspect the site again. Repeat re-application
   Matrix Component and deliver the sterile inner                if necessary.
   package to the sterile field. Once placed on the           • Once bleeding has ceased, excess FloSeal Matrix,
   operating field, the inner package may be opened             material not incorporated in the hemostatic clot,
   at any time.                                                 should be removed by gentle irrigation.
Preparing the Thrombin Solution                               • Do not disrupt the FloSeal Matrix-clot complex by
                                                                physical manipulation. FloSeal incorporated in
 • Remove the plastic flip-off cap from the Calcium
                                                                the hemostatic clot should be left in situ.
   Chloride Solution vial. Remove the plastic flip-off
   cap from the Thrombin vial. Disinfect the rubber
   stoppers of both vials with a germicidal solution         For Nasal/Sinus Applications:
   and allow to dry. Do not use iodine-containing
   preparations such as betadine for disinfection.           For endoscopic sinus surgery and epistaxis
 • Using the 5 mL syringe with needle attached                • Deliver FloSeal Matrix to the source of bleeding
   provided in the Thrombin Component package,                  using a non-traumatic applicator of appropriate
   transfer all 5 mL of Calcium Chloride Solution to            length attached to the FloSeal Matrix syringe.
   the vial containing the lyophilized Thrombin. Keep
   the 5 mL syringe with needle attached in the               • Apply sufficient FloSeal Matrix to liberally cover
   Thrombin vial. Discard the empty Calcium                     the entire bleeding surface.
   Chloride Solution vial appropriately.                      • Using forceps or other appropriate instrument,
 • Gently swirl the Thrombin vial until the Thrombin            carefully layer a moistened cottonoid over the
   is completely dissolved. Once reconstituted, the             FloSeal Matrix for 1-2 minutes to ensure the
   Thrombin Solution should be used promptly.                   material remains in contact with the bleeding
   However, the Solution may be used up to 4 hours              tissue. In cases of persistent bleeding, indicated
   after reconstitution.                                        by saturation and bleeding through the granules,
                                                                insert the applicator tip through the center of the
  • Aspirate the Thrombin solution into the syringe.            mass of previously placed FloSeal Matrix to
    Transfer the Thrombin solution into the sterile             deliver fresh material as close as possible to the
    field by dispensing into the small bowl provided in         tissue surface. After re-application of FloSeal
    the Gelatin Matrix Component package. Discard               Matrix, use a moistened cottonoid to approximate
    both the empty Thrombin vial and 5 mL syringe               the material to the tissue for another minute, and
    with needle attached appropriately.                         then inspect the site. Repeat re-application if
Mixing the Thrombin Solution into the Gelatin Matrix            necessary.

 • An empty 5 mL syringe with an integral female              • Once hemostasis has been achieved, remove the
   Luer connector is provided with the Gelatin Matrix           cottonoid Excess FloSeal Matrix should be
   Component. Using this syringe, aspirate the                  removed with gentle irrigation or careful suction.
   Thrombin solution from the small bowl into the               Avoid disrupting the FloSeal Matrix-clot complex.
   syringe to the indicated mark (4 mL).                      • FloSeal Matrix does not have to be removed
 • Remove the Luer cap from the Gelatin Matrix                  postoperatively as it is bioresorbed.
   Syringe carefully to avoid spilling the Gelatin            • Use of nasal packing has not been necessary
   Matrix granules. Connect this syringe to the                 when satisfactory hemostasis has been achieved
   syringe containing the Thrombin solution. Push               with FloSeal.
   the plunger of the Thrombin solution syringe to            • The use of FloSeal Matrix for mechanical support
   fully pass the solution into the syringe containing          has not been studied.
   the Gelatin Matrix. This constitutes “one pass”.
   Transfer the Gelatin Matrix-Thrombin solution
   mixture back and forth between the syringes for a         Storage Conditions:
   total of at least twenty passes. While starting to        The FloSeal Matrix package should be stored at 2 -
   mix, do not try to force large, dry clumps of the         25°C (36 - 77°F). Do not freeze.
   Gelatin Matrix through the Luer connector, as it
                                                             Manufactured by:
   may clog. After the first several passes, most of
                                                             Baxter Healthcare Corporation
   the Gelatin Matrix should be hydrated, and the
                                                             Fremont, CA 94555, USA
   contents should then be passed rapidly between            Customer Service 1 800 423 2090
   the syringes to promote thorough mixing. The
   FloSeal material should be in the FloSeal Matrix          Reorder No.: 934057 (Case of 6)
   branded syringe at the completion of mixing.
                                                             Baxter and FLOSEAL are trademarks of Baxter
 • Ensure the syringe labeled FloSeal contains the           International Inc. FEIBA is a trademark of Baxter AG.
   FloSeal Matrix.                                           Baxter, FEIBA and FLOSEAL are registered in the US
                                                             Patent and Trademark Office.
 • If desired, connect an Applicator tip to the FloSeal
   Matrix syringe. FloSeal Matrix may also be                Portions of this package are covered by US Patents
   extruded directly from the syringe.                       #4,640,834, #5,209,776, #5,292,362, #5,714,370,
                                                             #6,063,061 and #6,066,325, European Patent No.
 • Product consistency may not be optimal if used
                                                             EP0542880B1, and by other pending patent applica-
   prior to 30 seconds after preparation.
 • FloSeal Matrix may be used up to two (2) hours
   after mixing with the Thrombin Solution.                  Label Code: 0700822
                                                             Rev: 0 Rev. Date: 03/05
 • If desired, transfer FloSeal Matrix to a smaller
                                                             Lit. No. 45010
    syringe (e.g. 3 mL) for extrusion through longer
    applicator tips.
                                                             Definition of Symbols:
FloSeal Matrix Placement/Application:

Do not inject FloSeal Matrix into blood vessels. See                             Attention, see instructions for use
the Contraindications, Warnings, Precautions, and
Adverse Events sections contained in these Instructions                          Do not reuse
for Use.

For best results, FloSeal Matrix should be in complete                           Sterile
contact with the actively bleeding tissue surface.

The particles of FloSeal Matrix swell approximately                              Sterilized using irradiation
20% upon contact with blood or other fluids. Maximum
swell volume is achieved within about 10 minutes.             LATEX              Latex-free

Application Technique
                                                                                 Mix thrombin solution
 • Identify the source of bleeding at the tissue
   surface. This is the target site for FloSeal Matrix
   application.                                                                  Swoosh gelatin: Mix thrombin
 • Manually approximate a gauze sponge moistened                                 solution with Gelatin
   with sterile (non-heparinized) saline against the
   bleeding surface and use the Applicator tip (or
   syringe tip) to dispense FloSeal Matrix between                               Apply FloSeal
   the sponge and the bleeding surface. The gauze
   sponge will hold FloSeal Matrix in place against
   the bleeding surface in the presence of active
   bleeding. Apply enough FloSeal Matrix to create a
   small “mound” of material at the source of
 • For tissue defects (“divots” or “craters”), begin
   applying FloSeal Matrix at the deepest part of the
   lesion, and continue applying material as the
   syringe (or Applicator tip, if used) is withdrawn
   from the lesion. This “back-filling” action will
   ensure that FloSeal Matrix comes into contact
   with the entire bleeding surface at the tissue
 • Apply a gauze sponge to approximate the FloSeal
   Matrix against the bleeding surface, conforming it
   to the lesion.
 • After approximately two minutes, lift the gauze
   sponge and inspect the wound site. If bleeding
   has ceased, excess FloSeal Matrix (not
   incorporated in the hemostatic clot) should be
   removed by gentle irrigation.

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