Changing the Story of Lung Cancer
Changing the Story of Lung Cancer

Ethicon is partnering with healthcare leaders worldwide, developing innovative solutions aimed at boosting long-term survival rates for lung cancer patients.

Shaping the Future of Surgery

Over a Century of Meaningful Innovation

At Ethicon, weʼre focused on improving health outcomes for patients and helping solve the greatest health challenges… with only meaningful innovation. The kind that led to the creation of the first sutures, that helped revolutionize surgery with minimally invasive procedures, and that elevates standards of care around the world.

News & Events
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Ethicon Announces 510(K) Clearances for VISTASEAL Open and Laparoscopic Dual Applicator Devices Designed to Deliver Biologics That Address Surgical Bleeding
VISTASEAL Dual Applicator is the First Product to Emerge from Recent Strategic Partnership Between Ethicon and Grifols, Leading Maker of Plasma-Derived Medicines
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Pulmonary Artery Branch Sealing with Ultrasonic Energy Device Shows Promise in Minimally Invasive Lung Cancer International Clinical Trial
Preliminary Findings Presented at American Association for Thoracic Surgery Annual Meeting
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LINX Reflux Management System Has Been Shown to Reduce Medical Costs More Than Traditional Anti-Reflux Surgery in First Year Following Procedure
New Study Shows LINX treatment Lowers Overall Medical Expenses for GERD and other Health Issues
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Ethicon Launches Global Registry to Collect Real-World Data on Liver Lesions Ablated With the Neuwave Microwave Ablation System
References

* Benchtop testing in porcine tissue ≤30mmHg (26mmHg average pressure experienced during intra-operative leak test), comparing Ethicon ECHELON CIRCULAR™ Powered Stapler CDH25P to Medtronic DST Series™ EEA™ Stapler EEA2535 (p<0.001) and preclinical perfusion model, in which perfusion was not significantly different between devices.

1. Lissovoy, G. D., Fraeman, K., Hutchins, V., Murphy, D., Song, D., & Vaughn, B. B. (2009). Surgical site infection: Incidence and impact on hospital utilization and treatment costs. American Journal of Infection Control, 37(5), 387-397.

2. Ming X, Rothenburger S, Nichols MM. In vivo and in vitro antibacterial efficacy of PDS Plus (polidioxanone with triclosan) suture. Surg Infect (Larchmt). 2008;9(4):451-457.

3. Ming X, Rothenburger S, Nichols MM, Rothenburger S. In Vivo Antibacterial Efficacy of MONOCRYL Plus Antibacterial (Poliglecaprone 25 withTriclosan) Suture. Surg Infect (Larchmt). 2007; 8(2):1-5.

4. Rothenburger S, Spangler D, Bhende S, Burkley D. In vitro antimicrobialevaluation of coated Vicryl Plus Antibacterial Suture (coated polyglactin 910 with triclosan) using zone of inhibition assays. Surg Infect (Larchmt). 2002;3 (suppl):S79-S87.

5. P960052B.

6. Data on File. Keplinger 07PD0748. Protocol investigation of the comparison of PRINEO with conventional wound closure techniques. 

7. US Market Share Report, October 2016. Ethicon, Inc.
8. SURGICEL® Technical Report, 2018. Ethicon, Inc.  
9. Hong YM, Loughlin KR. The use of hemostatic agents and sealants in urology. J Urol. 2006;176(6 Pt 1):2367-2374.
10. SURGICEL® Absorbable Hemostat. Full Prescribing Information. Ethicon, Inc. 

11. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. doi:10.1001/jamasurg.2017.0904.
12. WHO Global Guidelines for the Prevention of Surgical Site Infection, 2016.
13. Ban KA, Minei JP, Laronga C, et al. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2016;224:59-74. 

14. Ethicon retrospective analysis of economic and clinical outcomes comparing the use of Echelon Powered vs. Medtronic non-powered endoscopic surgical staplers to treat patients undergoing video-assisted thoracoscopic surgery lobectomy.Review of 3,006 cases between 2012 and 2015 from the Premier Perspective® Hospital Database. Data assessed included length of stay, total hospital cost, supply cost, room & board cost, incidence of transfusion, and incidence of hemostasis-related complications; all p ≤ 0.05.

15. Ex-vivo data available in probe Instructions For Use. See PL-000006, PL-000009, PL-000026, PL-000050, PL-000239, PL-000240 and PL-000243. 

16. Laeseke et al. Multiple-Antenna Microwave Ablation: Spatially Distributing Power Improves Thermal Profiles and Reduces Invasiveness. Journal of Interventional Oncology. 2009; 2(2):105-112. Brace et al. Simultaneous Activation of Multiple Microwave Antennas Improves Circularity and Ablation Zone Volume Compared to Sequentially Overlapping Ablations. Presented at conference with accompanying poster, WCIO 2014.

17. Chalmers RT, Darling RC III, Wingard JT, et al. Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures. Br J Surg. 2010;97(12):1784–1789. 

18. STAR ASA coverage area test using corium tissue on a 45 degree tilted plane. September 2014. Ethicon, Inc.

19. Quinn J, Wells G, Sutcliffe T, et al. A randomized trial comparing octylcyanoacrylate tissue adhesive and sutures in the management of lacerations. JAMA. 1997;277(19):1527-1530.

20. Singer AJ, Perry LC, Allen RL. In vivo study of wound-bursting strength and compliance of topical skin adhesives. Acad Emerg Med. 2008;15(12):1290-1294.

21. Bhende S, Rothenburger S, Spangler DJ, Dito M. In vitro assessment of microbial barrier properties of DERMABOND® Topical Skin Adhesive. Surg Infect (Larchmt). 2002;3(3):251-257.

SURGICEL Essential Product Information

INDICATIONS
SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective. SURGICEL® ORIGINAL, SURGICEL® FIBRILLAR™, SURGICEL® NU-KNIT®, and SURGICEL® SNoW™ Absorbable Hemostats can be cut to size for use in endoscopic procedures.

PRECAUTIONS
Use only as much SURGICEL® Absorbable Hemostat as is necessary for hemostasis, holding it firmly in place until bleeding stops. Remove any excess before surgical closure in order to facilitate absorption and minimize the possibility of foreign body reaction.

In urological procedures, minimal amounts of SURGICEL® Absorbable Hemostat should be used and care must be exercised to prevent plugging of the urethra, ureter, or a catheter by dislodged portions of the product.

Since absorption of SURGICEL® Absorbable Hemostat could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemicals.

If SURGICEL® Absorbable Hemostat is used temporarily to line the cavity of large open wounds, it should be placed so as not to overlap the skin edges. It should also be removed from open wounds by forceps or by irrigation with sterile water or saline solution after bleeding has stopped.

Precautions should be taken in otorhinolaryngologic surgery to assure that none of the material is aspirated by the patient. (Examples: controlling hemorrhage after tonsillectomy and controlling epistaxis.)

Care should be taken not to apply SURGICEL® Absorbable Hemostat too tightly when it is used as a wrap during vascular surgery (see Adverse Reactions section of the complete product package insert).

ADVERSE EVENTS
“Encapsulation” of fluid and foreign body reactions have been reported.

There have been reports of stenotic effect when SURGICEL® Absorbable Hemostat has been applied as a wrap during vascular surgery.

Paralysis and nerve damage have been reported when SURGICEL® Absorbable Hemostat was used around, in, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm.

Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when SURGICEL® Absorbable Hemostat was placed in the anterior cranial fossa.

Possible prolongation of drainage in cholecystectomies and difficulty passing urine per urethra after prostatectomy have been reported.

For more information, please consult your doctor or for product quality and technical questions, call 1-800-795-0012. For complete product information including indications, contraindications, warnings, precautions, and adverse reactions, please reference the individual product package inserts.

SURGICEL® Powder Absorbable Hemostat Essential Product Information

INDICATIONS
SURGICEL® Powder (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective.

CONTRAINDICATIONS
Do not inject or place SURGICEL® Powder into an open blood vessel. Do not use to treat bleeding from large defects in arteries or veins.

SURGICEL® Powder should not be used to control hemorrhage from large arteries or veins.

When SURGICEL® Powder is used to help achieve hemostasis in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, or the optic nerve and chiasm, it must always be removed after hemostasis is achieved since it will swell and could exert unwanted pressure.

SURGICEL® Powder should not be used for implantation in bone defects, such as fractures, since there is a possibility of interference with callus formation and a theoretical chance of cyst formation.

WARNINGS
Closing with SURGICEL® Powder in a contaminated wound without drainage may lead to complications and should be avoided.

SURGICEL® Powder should not be impregnated with anti-infective agents or with other materials such as buffering or hemostatic substances. 

SURGICEL® Powder is dry and there may be difficulties in precise delivery under certain circumstances. Unintentional device placement may result in powder scattering and device migration that may increase the risk of adhesion formation. 

Although SURGICEL® Powder is bactericidal against a wide range of pathogenic microorganisms, it is not intended as a substitute for systemically administered therapeutic or prophylactic antimicrobial agents to control or to prevent postoperative infections.

Do not attempt to trim the applicator tip.

PRECAUTIONS
SURGICEL® Powder should not be used in conjunction with autologous blood salvage circuits, because its fragments may pass through the transfusion filters of blood-scavenging systems.

Use only as much SURGICEL® Powder (oxidized regenerated cellulose) as is necessary and apply only where needed for hemostasis. Remove any excess before surgical closure in order to facilitate absorption and to minimize the possibility of foreign body reaction.

In urological procedures, minimal amounts of SURGICEL® Powder should be used and care must be exercised to prevent plugging of the urethra, ureter, or a catheter by dislodged portions of the product.

Since absorption of SURGICEL® Powder could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemicals.

If SURGICEL® Powder is used temporarily to line the cavity of open wounds, it should be removed by irrigation with sterile water or saline solution after bleeding has stopped.

Precautions should be taken in otorhinolaryngologic surgery to ensure that none of the material is aspirated by the patient (e.g., controlling hemorrhage after tonsillectomy and controlling epistaxis).

This applicator tip is not intended for laparoscopic or other endoscopic use.

ADVERSE EVENTS 
Paralysis and nerve damage have been reported when other SURGICEL® products were used around, in, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm. 

Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when other SURGICEL® products were placed in the anterior cranial fossa (see WARNINGS and PRECAUTIONS).

Foreign body reactions have been reported with other products from the SURGICEL® Family of Absorbable Hemostats.

Burning has been reported when other SURGICEL® products were applied after nasal polyp removal. Headache, burning, stinging, and sneezing in epistaxis and other rhinological procedures, and stinging when SURGICEL® product was applied on surface wounds (varicose ulcerations, dermabrasions, and donor sites) have also been reported.

For more information and technical questions, call 1-800-795-0012.  For complete information including indications, contraindications, warnings, precautions, adverse reactions, and directions for use, consult the product package insert.

EVICEL® Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION

Indication
EVICEL® Fibrin Sealant (Human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.

Contraindications
▪    Do not inject directly into the circulatory system. Intravascular application of EVICEL® may result in life-threatening thromboembolic events.

▪    Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.

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

▪    Do not use EVICEL® for spraying in endoscopic or laparoscopic procedures where the minimum recommended distance from the applicator tip to the target site cannot be ensured.

Warnings and Precautions
▪    Life-threatening air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer EVICEL®. This event appears to be related to the use of the spray device at pressures higher than recommended and/or at distances closer than recommended to the surface of the tissue.

▪    Monitor changes in blood pressure, pulse, oxygen saturation, and end-tidal CO2 when spraying EVICEL® because of the possibility of gas embolism.

▪    To reduce the risk of potentially life-threatening gas embolism, spray EVICEL® using only pressurized CO2 gas at the pressures and distances recommended for the specific tips.

▪    Use EVICEL® spray application only if it is possible to accurately judge the spray distance, especially during endoscopic or laparoscopic procedures.

▪    Prior to applying EVICEL®, dry surface areas of the wound by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices). Prepare and administer EVICEL® according to the instructions and with only devices recommended for this product.
▪    May carry a risk of transmitting infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most common adverse reactions reported in clinical trials are peripheral edema, abdominal abscess, infection, hematoma, incision site hemorrhage, vascular graft occlusion, postoperative wound complication and decreased hemoglobin.

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

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