Fully Sterile - Ethicon fully sterile design gives you the flexibility to ... (spine fusion or...

Fully Sterile Fully

Sterile

Flexibility for thrombin preparation inside or outside the sterile field

When diff icult-to-access bleeding limits your visibility,

SURGIFLO® Hemostatic Matrix Kit works fast to make things clear.1

10.75”11”11”

8.5”

8.5”

8.5”

Safety and Efficacy • Achieves hemostasis within approximately 60 seconds3*

Consistency• Preferred consistency among surgeons4†

• Remains uniformly consistent throughout lengthy,

complex procedures5

Ease Of Use • Flexibility to prepare inside or outside the sterile field

• Faster to prepare than Floseal and requires no measuring6

Economic Value • SURGIFLO® was associated with significant cost reduction

compared to Floseal7

*In animal models. †Testing conducted with 101 US surgeons.

SURGIFLO® Hemostatic Matrix Kit helps achieve visibility fast during critical moments

SURGIFLO® achieves similar clinical outcomes compared to Floseal and offers so much more2

MECHANISM of ACTION

Gelatin:The flowable gelatin matrix provides an environment for platelets to adhere and aggregate within, building on the patient’s natural coagulation cascade.

Thrombin:Enhancing the tamponade of the gelatin matrix, the thrombin component of SURGIFLO® Hemostatic Matrix Kit acts as a catalyst and activates the patient’s endogenous fibrinogen, accelerating clot formation.

Once bleeding has ceased, irrigate excess SURGIFLO® away gently so as not to disturb the new clot. When used in appropriate amounts, SURGIFLO® is absorbed completely within 4-6 weeks.

Platelets adhered to gelatin andplatelets activated by thrombin.

Fibrin is formed by the interaction of the thrombin with

endogenous fibrinogen.Surface of gelatin granule.

11”11”

8.5”

ECONOMIC OUTCOME

SURGIFLO® Hemostatic Matrix Kit offers cost savingswith similar outcomes when compared to Floseal7

Number of hospitals: 121

Number of

procedures: 16,586(spine fusion or refusion)

Little or no difference in clinical outcomes (transfusions,

hemorrhage, wound complications)

Peer-reviewed article in

Journal of Medical Economics

As the duration of the spinal surgery

increases, so does the potential to reduce

cost even further.19

Data source: Premier Perspective® Hospital Database

SURGIFLO® with thrombin

Floseal (with thrombin)

Hospital flowable cost per procedure18

n

1,498

Mean Cost

$222.66

n

15,088

Mean Cost

$349.80

Average flowable cost savings per procedure—$127.1418

SAFETY and EFFICACY

Clinical and preclinical data yielded similar results for SURGIFLO® Hemostatic Matrix Kit and Floseal

A systematic review of 6 clinical studies across 39,660 patients comparing SURGIFLO® with thrombin and Floseal showed both products yielded similar safety and efficacy outcomes.8

SURGIFLO® and Floseal were assessed across the following indicators8:

The studies found no statistically significant differences8

• In a porcine spleen model of bleeding injury, SURGIFLO® withthrombin performed similarly to Floseal with thrombin9*

• Hemostasis was achieved within 3 minutes at all sites for bothproducts regardless of level of initial bleeding9

Clinical Preclinical

Time to Hemostasis for Different Types of Bleeding: SURGIFLO® versus Floseal (Spleen Biopsy Model)9*

92.2 s

54.9 s

44.3 s

Floseal SURGIFLO®

72.3 s

56.7 s

51.8 s

Spurting

Flowing

Oozing

Average Time to Hemostasis

SURGIFLO®

59 s

Floseal

57 sHemostasis in <7 minutes

Major complications

Blood transfusions

Minor complications

Length of hospital stay

Surgical/operating room time

*n=3 pigs, 18 samples per pig.

11”11”

8.5”

EASE OF USE

SURGIFLO® Hemostatic Matrix Kit:Innovative fully sterile design gives you the flexibility toprepare thrombin inside or outside the sterile field14

Fully Sterile

Faster and easier to prepare versus Floseal6

• More than two minutes shorter thrombin reconstitution time versus Floseal (13 seconds for SURGIFLO® vs 136 seconds for Floseal*)15

• Requires no measuring6

• Does not require 30-second wait time after mixing• Needle-free design pioneered by Ethicon16

Sterile Prep Nonsterile Prep

Three tip designs offer a variety of options:

Endoscopic applicator delivers nearly 5 times more product than competition in a single expression17

Flexible tip offers precise placement at any angle12

Trimmable tip offers a customizable length

CONSISTENCY

Adherent

Stays in place during active bleeding11

Precise

Malleable tip allows precise placement in

difficult-to-access areas, cavities, and crevices12

Better Packing

Greater conformability and more tissue

surface contact13

The premoistened gelatin mixes uniformly with the thrombin to ensure the matrix retains consistency throughout the length of the syringe and for up to 8 hours 5,10

0.0026.3% variation

57.6% variation

Flu

idit

y (P

A•S

1 )

0.0015

0.001

0.0005

0

STA

RT

STA

RT

FIN

ISH

FIN

ISH

MID

DLE

MID

DLE

FlosealSURGIFLO®

Get the consistency you prefer that stays uniform over an 8-hour procedure5,10

In blind testing, surgeons prefer the consistency of SURGIFLO® Hemostatic Matrix Kit over Floseal4*

*Testing conducted with 101 US surgeons. *Versus 10mL Floseal kit.

11”11”

8.5”

EASE OF USE

SURGIFLO® Hemostatic Matrix Kit:Innovative fully sterile design gives you the flexibility to prepare thrombin inside or outside the sterile field14

Fully Sterile

Faster and easier to prepare versus Floseal6

• More than two minutes shorter thrombin reconstitution timeversus Floseal (13 seconds for SURGIFLO® vs 136 secondsfor Floseal*)15

• Requires no measuring6

• Does not require 30-second wait time after mixing• Needle-free design pioneered by Ethicon16

Sterile Prep Nonsterile Prep

Three tip designs offer a variety of options:

Endoscopic applicator delivers nearly 5 times more product than competition in a single expression17†

Flexible tip offers precise placement at any angle12

Trimmable tip offers a customizable length

CONSISTENCY

Adherent

Stays in place during active bleeding11

Precise

Malleable tip allows precise placement in

difficult-to-access areas, cavities, and crevices12

Better Packing

Greater conformability and more tissue

surface contact13

The premoistened gelatin mixes uniformly with the thrombin to ensure the matrix retains consistency throughout the length of the syringe and for up to 8 hours 5,10

0.0026.3%variation

57.6%variation

Flu

idit

y (P

A•S

1 )

0.0015

0.001

0.0005

0

STA

RT

STA

RT

FIN

ISH

FIN

ISH

MID

DLE

MID

DLE

FlosealSURGIFLO®

Get the consistency you prefer that staysuniform over an 8-hour procedure5,10

In blind testing, surgeons prefer the consistency of SURGIFLO® Hemostatic Matrix Kit over Floseal4*

*Testing conducted with 101 US surgeons. *Versus 10mL Floseal kit.Not intended to convey comparative safety or efficacy.†

11”11”

8.5”

ECONOMIC OUTCOME

SURGIFLO® Hemostatic Matrix Kit offers cost savings with similar outcomes when compared to Floseal7

Number of hospitals: 121

Number of

procedures: 16,586(spine fusion or refusion)

Little or no difference in clinical outcomes (transfusions,

hemorrhage, wound complications)

Peer-reviewed article in

Journal of Medical Economics

As the duration of the spinal surgery

increases, so does the potential to reduce

cost even further.19

Data source: Premier Perspective® Hospital Database

SURGIFLO® with thrombin

Floseal (with thrombin)

Hospital flowable cost per procedure18

n

1,498

Mean Cost

$222.66

n

15,088

Mean Cost

$349.80

Average flowable cost savings per procedure—$127.1418

SAFETY and EFFICACY

Clinical and preclinical data yielded similar results for SURGIFLO® Hemostatic Matrix Kit and Floseal

A systematic review of 6 clinical studies across 39,660 patients comparing SURGIFLO® with thrombin and Floseal showed both products yielded similar safety and efficacy outcomes.8

SURGIFLO® and Floseal were assessed across the following indicators8:

The studies found no statistically significant differences8

• In a porcine spleen model of bleeding injury, SURGIFLO® with thrombin performed similarly to Floseal with thrombin9*

• Hemostasis was achieved within 3 minutes at all sites for both products regardless of level of initial bleeding9

Clinical Preclinical

Time to Hemostasis for Different Types of Bleeding: SURGIFLO® versus Floseal (Spleen Biopsy Model)9*

92.2 s

54.9 s

44.3 s

Floseal SURGIFLO®

72.3 s

56.7 s

51.8 s

Spurting

Flowing

Oozing

Average Time to Hemostasis

SURGIFLO®

59 s

Floseal

57 sHemostasis in <7 minutes

Major complications

Blood transfusions

Minor complications

Length of hospital stay

Surgical/operating room time

*n=3 pigs, 18 samples per pig.

10.75”11”11”

8.5”

8.5”

8.5”

Safety and Efficacy • Achieves hemostasis within approximately 60 seconds3*

Consistency• Preferred consistency among surgeons4†

• Remains uniformly consistent throughout lengthy,

complex procedures5

Ease Of Use • Flexibility to prepare inside or outside the sterile field

• Faster to prepare than Floseal and requires no measuring6

Economic Value • SURGIFLO® was associated with significant cost reduction

compared to Floseal7

*In animal models. †Testing conducted with 101 US surgeons.

SURGIFLO® Hemostatic Matrix Kit helps achieve visibility fast during critical moments

SURGIFLO® achieves similar clinical outcomes compared to Floseal and offers so much more2

MECHANISM of ACTION

Gelatin:The flowable gelatin matrix provides an environment for platelets to adhere and aggregate within, building on the patient’s natural coagulation cascade.

Thrombin: Enhancing the tamponade of the gelatin matrix, the thrombin component of SURGIFLO® Hemostatic Matrix Kit acts as a catalyst and activates the patient’s endogenous fibrinogen, accelerating clot formation.

Once bleeding has ceased, irrigate excess SURGIFLO® away gently so as not to disturb the new clot. When used in appropriate amounts, SURGIFLO® is absorbed completely within 4-6 weeks.

Platelets adhered to gelatin andplatelets activated by thrombin.

Fibrin is formed by the interaction of the thrombin with

endogenous fibrinogen.Surface of gelatin granule.

10.75” 11” 11”

8.5”8.5”

8.5”

Shaping the future of surgery


When difficult-to-access bleeding limits your

visibility, SURGIFLO® Hemostatic Matrix Kit works

fast to make things clear1

Fully Sterile

SURGIFLO® Hemostatic Matrix Kit with thrombin

For technical support, call 1-877-ETHICON.

For additional information, visit www.ethicon.com

Call 1-800-255-2500 to order.

SURGIFLO®

Ordering code Size Package

29948 mL SURGIFLO® Hemostatic Matrix Kit with thrombin (fully sterile)

Case of 6

2991 8 mL SURGIFLO® Hemostatic Matrix Case of 6

MS1995 34 cm Endoscopic Applicator Case of 6

© 2017 Ethicon US, LLC. 040237-150911

Fully Sterile

SURGIFLO® Hemostatic Matrix Kit Essential Product Information (Made from Absorbable Gelatin Sponge, USP) with Thrombin

DESCRIPTION

SURGIFLO® with Thrombin (SURGIFLO® Hemostatic Matrix Kit) is intended for hemostatic use by applying to a bleeding surface.

ACTIONS

When used in appropriate amounts SURGIFLO® is absorbed completely within 4 to 6 weeks.

INTENDED USE/INDICATIONS

SURGIFLO®, mixed with thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.

CONTRAINDICATIONS

• Do not use SURGIFLO® in intravascular compartments because of the risk of embolization.

• Do not use SURGIFLO® in patients with known allergies to porcine gelatin.

• Do not use SURGIFLO® in closure of skin incisions because it may interfere with the healing of skin edges. This interference is due to mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing.

WARNINGS

• SURGIFLO® should not be used in the presence of infection and should be used with caution in contaminated areas of the body

• SURGIFLO® should not be used in instances of pumping arterial hemorrhage. SURGIFLO® will not act as a tampon or plug in a bleeding site.

• SURGIFLO® should be removed from the site of application when used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm because it may swell, resulting in nerve damage.

• Excess SURGIFLO® should be removed once hemostasis has been achieved.

• The safety and effectiveness of SURGIFLO® for use in ophthalmic procedures has not been established.

• SURGIFLO® should not be used for controlling post-partum intrauterine bleeding or menorrhagia.

• The safety and effectiveness of SURGIFLO® has not been established in children and pregnant women.

• The blue flexible applicator tip should not be trimmed to avoid exposing internal guidewire.

• The white straight applicator tip should be trimmed away from the surgical area. Cut a square angle to avoid creating a sharp tip.

PRECAUTIONS

• Safe and effective use of SURGIFOAM® Sponge has been reported in a published neurologic retrospective study involving 1700 cases in Europe. Safe and effective use in neurosurgery has not been proven through randomized, controlled clinical studies in the United States.

• SURGIFLO® is supplied as a sterile product and cannot be resterilized.

• SURGIFLO® should not be used for packing unless excess product that is not needed to maintain hemostasis is removed. SURGIFLO® may swell up to 20% upon contact with additional fluid.

• SURGIFLO® should not be used in conjunction with autologous blood salvage circuits.

• SURGIFLO® should not be used in conjunction with methylmethacrylate adhesives.

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

ADVERSE EVENTS

A total of 142 patients received SURGIFOAM® Sponge during a clinical trial comparing SURGIFOAM® Sponge to another absorbable gelatin sponge. In general, the following adverse events have been reported with the use of absorbable porcine gelatin-based hemostatic agents:

• Gelatin-based hemostatic agents may serve as a nidus for infection and abscess formation and have been reported to potentiate bacterial growth.

• Giant cell granulomas have been observed at implant sites when used in the brain.

• Compression of the brain and spinal cord resulting from the accumulation of sterile fluid have been observed.

• Multiple neurologic events were reported when absorbable gelatin-based hemostatic agents were used in laminectomy operations, including cauda equina syndrome, spinal stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction, and impotence.

• The use of absorbable gelatin-based hemostatic agents during the repair of dural defects associated with laminectomy and craniotomy operations, has been associated with fever, infection, leg paresthesias, neck and back pain, bladder and bowel incontinence, cauda equina syndrome, neurogenic bladder, impotence, and paresis.

• The use of absorbable gelatin-based hemostatic agents has been associated with paralysis, due to device migration into foramina in the bone around the spinal cord, and blindness, due to device migration in the orbit of the eye, during lobectomy, laminectomy, and repair of a frontal skull fracture and lacerated lobe.

• Foreign body reactions, “encapsulation” of fluid, and hematoma have been observed at implant sites.

• Excessive fibrosis and prolonged fixation of a tendon have been reported when absorbable gelatin-based sponges were used in severed tendon repair.

• Toxic shock syndrome was reported in association with the use of absorbable gelatin-based hemostats in nasal surgery.

• Fever, failure of absorption, and hearing loss have been observed when absorbable hemostatic agents were used during tympanoplasty.

063756-161128

EVITHROM® Thrombin, Topical (Human) for Topical Use Only

Lyophilized Powder for Solution

EVITHROM® is a topical thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control

of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.

EVITHROM® may be used in conjunction with an Absorbable Gelatin Sponge, USP.

Important Safety Information• For topical use only.

• Do not inject.

• Apply EVITHROM® on the surface of bleeding tissue only.

• The amount of EVITHROM® required depends upon the area of tissue to be treated and the method of application. In clinical studies, volumes up to 10 ml were used in

conjunction with Absorbable Gelatin Sponge.

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

• Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products. Hypersensitivity reactions, including anaphylaxis, may occur.

• There is a potential risk of thrombosis if absorbed systemically.

• May carry a risk of transmitting infectious agents such as viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite manufacturing steps designed to

reduce the risk of viral transmission.

• The most common adverse reactions during clinical trial (reported in at least 2% of subjects treated with EVITHROM®) were prolonged activated partial thromboplastin

time, increased INR, decreased lymphocyte count, prolonged prothrombin time and increased neutrophil count.

• None of the patients treated with EVITHROM developed antibodies to human thrombin or to human Factor V/Va. The clinical significance of these findings is unknown.

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

021328-140912

References:1. Data on File, Ethicon Inc., SURGIFLO® Hemostatic Matrix Kit Claim_(048237-160301)

2. Data on File, Ethicon Inc., SURGIFLO® Hemostatic Matrix Kit Claim_(048512-160304)






8. Systematic review and meta-analysis of hemostatic matrices for bleeding control, Valls et al, Johnson & Johnson Medical, Mexico City, Mexico.

9. Data on File, Ethicon Inc., Pilot evaluation comparing the time-to-hemostasis and hemostatic efficacy of SURGIFLO®, next generation SURGIFLO®, and Floseal

(all prepared with thrombin) in an acute punch biopsy porcine spleen model: Final report 11-071. June 7, 2011.






15. Data on File, Ethicon Inc., Comparison of Thrombin Reconstitution Time in SURGIFLO® Hemostatic Matrix Kit with Thrombin and Floseal Hemostatic Matrix: May 11, 2017.



18. Similar patient outcomes yet different hospital costs between flowable hemostatic agents, David et al, JME, 2015.


.

10.75”11”11”

8.5” 8.5”

8.5”






Fully Sterile




Call 1-800-255-2500 to order.

SURGIFLO®

Ordering codeSizePackage


Case of 6

29918 mL SURGIFLO® Hemostatic MatrixCase of 6

MS199534 cm Endoscopic ApplicatorCase of 6

© 2017 Ethicon US, LLC. 040237-150911

Fully Sterile


DESCRIPTION


ACTIONS




CONTRAINDICATIONS




WARNINGS










PRECAUTIONS







ADVERSE EVENTS












063756-161128







• Do not inject.













021328-140912





















.

anthony.seminara

Sticky Note

Marked set by anthony.seminara

10.75” 11” 11”

8.5”8.5”

8.5”






Fully Sterile




Call 1-800-255-2500 to order.

SURGIFLO®

Ordering code Size Package


Case of 6

2991 8 mL SURGIFLO® Hemostatic Matrix Case of 6

MS1995 34 cm Endoscopic Applicator Case of 6

© 2017 Ethicon US, LLC. 040237-150911

Fully Sterile


DESCRIPTION


ACTIONS




CONTRAINDICATIONS




WARNINGS










PRECAUTIONS







ADVERSE EVENTS












063756-161128







• Do not inject.













021328-140912





















.

Fully Sterile - Ethicon fully sterile design gives you the flexibility to ... (spine fusion or...

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