Adjunctive Haemostats

Adjunctive Haemostats

Ethicon offers the most comprehensive portfolio of adjunctive hemostats proven to deliver clinical performance and economic efficiencies for intraoperative bleeding management. Each hemostasis agent is designed to address a range of bleeding challenges

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Real-world evidence study showed a comprehensive portfolio with a systematic approach to surgical adjunctive hemostat use supported clinical outcomes and delivered economic efficiencies1


$168K Saved

The annual cost savings to the hospital exceeded $168,0001*

15% Spend Reduction

The hospital in which the HOP research was conducted saw a 15% reduction in spending per hemostat unit over the course of a year1*

High Surgeon Satisfaction

When asked about the success of both product conversion and implementation of the HOP program, surgeons and nurses were "Very Satisfied," based on a survey using a five-point rating scale.1

Most Comprehensive Portfolio Delivers More for Your Health System

Clinical Performance Backed By Evidence

Clinical Performance Backed By Evidence

Ethicon has a broad portfolio of adjunctive hemostats, each designed to manage a range
of bleeding challenges surgical teams may encounter. The breadth of the portfolio helps
enable the right adjunctive hemostat to be used at the right time.1

Measurable Cost Savings

Measurable Cost Savings

Our comprehensive portfolio and systematic approach to bleeding management allow you to manage category growth in three ways—supplier standardization, product utilization, and product consolidation.

Compared to primary methods of hemostasis alone, adjunctive hemostats have been associated with reduced use of hospital resources in the following ways:

Compared to primary methods of hemostasis alone, adjunctive hemostats have been associated with reduced use of hospital resources in the following ways:

  • Up to 35% fewer patients require blood transfusions2-7
  • Up to 4 days shorter length of hospital stay2,8
  • Up to 25 minutes reduced operating time8
  • Significantly reduces the likelihood of hospital readmission9
Partners in Education

Partners in Education

Tap into a wide range of adjunctive hemostat Professional Education events. Ethicon provides
opportunities for virtual, hands-on labs and expert exchanges to drive a standardized approach to
bleeding management.
 

The Most Comprehensive Portfolio Offers Solutions to Four Common Bleeding Types

SURGICEL Family of Absorbable Hemostats

SURGICEL Family of Absorbable Hemostats

Continuous Oozing will not stop with compression/simple packing. The solution for this bleeding is more time consuming than it is difficult.1 32‐68% of cases in open procedures experience disruptive bleeding events despite treatment with hemostats.10 Choose the topical absorbable hemostat that is right for your needs.

SURGIFLO Hemostatic Matrix

SURGIFLO Hemostatic Matrix

Stops Bleeding before FLOSEAL® is ready to use21,22** SURGIFLO™ Hemostatic Matrix is twice as fast to prepare versus Floseal (81 vs. 163 seconds) and requires no measuring.21δ SURGIFLO with Thrombin achieved hemostasis in under a minute in an animal model.22,23
 

VERASEAL Fibrin Sealant (Human)

VERASEAL Fibrin Sealant (Human)

No other fibrin sealant preps faster.11-14≤± Veraseal has been demonstrated to sustain hemostasis even in high-risk patients (friable tissues, anticoagulants and coagulopathies)15-19≠
 

SPONGOSTAN Absorbable Haemostatic Gelatin Sponge

SPONGOSTAN Absorbable Haemostatic Gelatin Sponge
 

Sterile, water-insoluble, malleable, porcine gelatin absorbable sponge intended for haemostatic use by applying to a bleeding surface.20  Indicated for surgical procedures (except ophthalmic) for haemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.20

All Adjunctive Haemostasis and Sealing Products

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References

*Based on US data

¥Up to 68% of cases in open procedures experience disruptive bleeding events despite treatment with hemostats

≠In 3 RCTs, haemostasis was achieved between 2-10 minutes and was sustained for the 10 min observational period (90.2% for Veraseal™ vs 69.8% for control)

≤Comparing 10ml thawing time for VERASEAL™ Dual Applicator vs competitors (Tisseel™ and Evicel™)

**Taking into consideration that: SURGIFLO™ Hemostatic Matrix is twice as fast to prepare versus Floseal (81 vs.163 seconds) and requires no measuring. Specific time 81 vs 163 seconds and that SURGIFLO™ Hemostatic Matrix with thrombin performs similarly to Floseal, achieving hemostasis within approximately 60 seconds of application, in animal models

δSpecific time 81 vs. 163 seconds

±Based on number of set-up steps and thawing time required for VERASEAL™ Dual Applicator vs competitors (Tisseel™ and Evicel™)

1.    Ferko, A systematic approach to surgical hemostat use supports standardization and cost efficiencies. Healthcare Purchasing News;2017;ePub;Nov 2017 (118636-190715, 119313-190724)

2.    Notarnicola A, Moretti L, Martucci A, Spinarelli A, Tafuri S, Pesce V, Moretti B. Comparative efficacy of different doses of fibrin sealant to reduce bleeding after total knee arthroplasty. Blood Coagul Fibrinolysis. 2012; 23 (4):278-284 (117999-210901)

3.    Molloy DO, Archbold HA, Ogonda L, McConway J, Wilson RK, Beverland DE. Comparison of topical fibrin spray and tranexamic acid on blood loss after total knee replacement: a prospective, randomised controlled trial. J Bone Joint Surg Br. 2007; 89 (3):306-309 (117999-210901)

4.    Sabatini L, Trecci A, Imarisio D, Uslenghi MD, Bianco G, Scagnelli R. Fibrin tissue adhesive reduces postoperative blood loss in total knee arthroplasty. J Orthop Traumatol. 2012; 13 (3):145-151 (117999-210901)

5.    Wang GJ, Hungerford DS, Savory CG, Rosenberg AG, Mont MA, Burks SG, Mayers SL, Spotnitz WD. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial. J Bone Joint Surg. 2001. 83-A (10):1503-1505 (117999-210901)

6.    Randelli F, Banci L, Ragone V, Pavesi M, Randelli G. Effectiveness of fibrin sealant after cementless total hip replacement: a double-blind randomized controlled trial. Int J Immunopathol Pharmacol. 2013; 26 (1):189-197 (117999-210901)

7.    Joseph T, Adeosun A, Paes T, Bahal V. Randomised controlled trial to evaluate the efficacy of TachoComb H Patches in Controllin PTFE Suture–hole Bleeding. Eur J Vasc Endovasc Surg. 2004; 27, 549–552 (117999-210901)

8.    Dancey AL, Cheema M, Thomas SS (2010) A prospective randomized trial of the efficacy of marginal quilting sutures and fibrin sealant in reducing the incidence of seromas in the extended latissimus dorsi donor site. Plast Reconstr Surg 125 (5):1309-1317 (117999-210901)

9.    Ye X, Rupnow MF, Hammond J, Shah M, Farrelly E. Readmission rates and hospital costs associated with fibrin sealant use among patients undergoing orthopaedic surgery.J Orthopaedics.2012;9 (1) e11 (117999-210901)

10.    Corral, Health and economic outcomes associated with uncontrolled surgical bleeding: a retrospective analysis of the Premier Perspectives Database,Clinico Economics and Outcomes Research;2015;7;409 (116962-190619)

11.    Ethicon, 100708726, Thawing time and set-up steps comparison between VISTASEAL™, EVICEL™ and TISSEEL™, Aug 2019, Data on File (137502-200420)

12.    TISSEEL™ Summary of Product Characteristics (137502-200420)

13.    VERASEAL™ Summary of Product Characteristics (137502-200420)

14.    EVICEL™ Summary of Product Characteristics (137502-200420)

15.    Chetter I, Stansby G, Sarralde JA, et al. A prospective, randomized, multicenter clinical trial on the safety and efficacy of a ready-to-use fibrin sealant as an adjunct to hemostasis during vascular surgery. Ann Vasc Surg:2017;45127–137 (137143-200416)

16.    Bjelovic M, Ayguasonosa J, Kim RD, et al. A prospective, randomized, phase III study to evaluate the efficacy and safety of fibrin sealant Grifols as an adjunct to hemostasis as compared to cellulose sheets in hepatic surgery resections. J Gastrointest Surg;2018: 221939–1949 (137143-200416)

17.    Hunt BJ. Bleeding and coagulapathies in critical care, N Engl J Med:2014:370:847-859 (137143-200416)

18.    Nenezic et al, A prospective, single-blind, randomized, phase III study to evaluate the safety and efficacy of Fibrin Sealant Grifols as an adjunct to hemostasis compared with manual compression in vascular surgery, Journal of Vascular Surgery;2019;1-10 (137143-200416)

19.    Lakshman, A Prospective, Single-Blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Soft Tissue Open Surgery, Journal of Investigative Surgery:0:1–13, 2018 (137143-200416)

20.    As Per Instructions For Use

21.    Ethicon, MD-TMSR-512-204.01 SURGIFLO™ Hemostatic Matrix Kit with Thrombin, Dec 2013, Data on File (150139-200817, 191419-211005)

22.    Ethicon, 07102013, Evaluation of the dose response curve for Hemostatic Efficacy of Surgiflo Next Generation mixed with Thrombin, Oct 2013, Data on File (150139-200817, 192073-211012))

23.    Langkilde, S. Evaluation of the dose response curve for Hemostatic Efficacy of Surgiflo Next Generation mixed with Thrombin, Report NG.162 2013;1-16 (192073-211012)

 

VeraSeal™ Solutions for sealant (human fibrinogen/human thrombin) Abbreviated Prescribing Information (API)

Please read Summary of Product Characteristics (SmPC) for full product information
before prescribing.

This medicinal product is subject to additional monitoring.

Composition
Component 1: Human fibrinogen 80 mg/ml
Component 2: Human thrombin 500 IU/ml

Therapeutic Indications:
VeraSeal™ is indicated as supportive treatment in adults where standard surgical techniques
are insufficient:
-for improvement of haemostasis.
-as suture support in vascular surgery.


CONTRAINDICATIONS
VeraSeal™ must not be applied intravascularly.
Hypersensitivity to the active substance or to any of the excipients listed in SmPC.
VeraSeal™ must not be used for the treatment of severe or brisk arterial bleeding.
Spray application of VeraSeal™ must not be used in endoscopic (intraluminal) procedures.
This medicinal product must not be mixed with other medicinal products.

Posology & administration
The use of VeraSeal™ is restricted to experienced surgeons who have been trained in the use
of this medicinal product.
The volume of VeraSeal™ to be applied and the frequency of application should always be
oriented towards the underlying clinical needs for the patient. The initial volume of the product
to be applied at a chosen anatomic site or target surface area should be suicient to entirely
cover the intended application area. The application can be repeated, if necessary.
The safety and efficacy of VeraSeal™ in children aged 0 to 18 years has not yet been established.

WARNINGS AND PRECAUTIONS
For epilesional use only.
Life threatening thromboembolic complications may occur if the preparation is unintentionally
applied intravascularly.
Adequate data are not available to support the use of this product in tissue gluing, neurosurgery,
application through a flexible endoscope for treatment of bleeding or in gastrointestinal
anastomoses. VeraSeal™ spray application should only be used if it is possible to accurately
judge the spray distance, especially during laparoscopy.
When using accessory tips, the instructions for use of the tips should be followed.
Before administration of VeraSeal™, care must be taken that the parts of the body outside the
desired application area are sufficiently protected (covered) to prevent tissue adhesion at
undesired sites.
VeraSeal™ should be applied as a thin layer. Excessive clot thickness may negatively interfere
with the product’s efficacy and the wound healing process.

As with any protein product, allergic type hypersensitivity reactions are possible.
When medicinal products prepared from human blood or plasma are administered, the
possibility of transmitting infective agents cannot be totally excluded. This also applies to
unknown or emerging viruses and other pathogens.

Undesirable effects
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at
the application site, bronchospasm, chills, flushing, generalized urticaria, headache, hives,
hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling,
vomiting, wheezing) may occur in rare cases in patients treated with fibrin sealant/haemostatic
products. In isolated cases, these reactions have progressed to severe anaphylaxis. Such
reactions may especially be seen, if the preparation is applied repeatedly, or administered to
patients known to be hypersensitive to constituents of the product. Antibodies against
components of fibrin sealant/haemostatic products may occur rarely. Inadvertent intravascular
injection could lead to thromboembolic event and disseminated intravascular coagulation (DIC),
and there is also a risk of anaphylactic reaction (Please refer to full SmPC).
For safety information with respect to transmissible agents, please refer to full SmPC.
The most common adverse reactions (frequencies of ≥1/100 to <1/10) were nausea, procedural
pain and pruritus.


Pregnancy and Breast Feeding
The safety of fibrin sealant/haemostatic products for use in human pregnancy or breast-feeding
has not been established in controlled clinical trials. Therefore, the product should be
administered to pregnant and breast-feeding women only if clearly needed.

SUPPLY CLASSIFICATION:
Medicinal product (biologic) subject to restricted medical prescription


MA HOLDER: Instituto Grifols, S.A., Can Guach, 2 - Parets del Vallès, E-08150 Barcelona, Spain


MA NUMBER(S):
EU/1/17/1239/001 2 ml, EU/1/17/1239/002 4 ml, EU/1/17/1239/003 6 ml, EU/1/17/1239/004 10 ml


DATE OF PREPARATION: October 2021


PHARMACOVIGILANCE:
Adverse events should be reported via the appropriate national reporting system. Adverse
events should also be reported to Instituto Grifols, S.A. by Email: [email protected]

Please refer always to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.


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