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
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
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
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 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
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.