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ETHICON LAUNCHES VISTASEAL FIBRIN SEALANT (HUMAN) TO MANAGE BLEEDING DURING SURGERY
Healthcare Professional View
Transforming Lives Together
Ethicon is committed to the science and treatment of obesity and in advancing Bariatric Surgery. Learn how Sonya’s bariatric surgery changed her life.
Shaping the Future of Surgery
Delivering Meaningful Innovation
VISTASEAL™ Fibrin Sealant (Human) mimics the clot formation process and forms a rapid, adherent, and durable clot regardless of the patient’s coagulation profile.1,2
Transforming Business Models
Over the last 20 years, Ethicon has contributed more to advancing bariatric surgery and the science and treatment of obesity than any other device maker. Learn about emerging Bariatric trends and procedures through our webinar series.
Responding With a Caring Spirit
Supporting medical relief projects,natural disaster response teams and basic healthcare needs in underserved communities.
Understanding Obesity and Set Point Theory
Learn more about Amanda’s weight loss journey as she discovers how the body keeps weight at a steady level or “set point” and its effect on appetite, digestion, energy balance and metabolism.
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.
1887 — Sterile Sutures
1887 — Sterile Sutures
Johnson & Johnson’s mass production of sterile sutures and other products ushered in the widespread practice of modern antiseptic surgery that dramatically raised survival rates.
1960 — SURGICEL<sup>®</sup> Original Absorbable Hemostat
1960 — SURGICEL® Original
SURGICEL® made history as the first oxidized regenerated cellulose hemostat and set a new standard for managing surgical bleeding.
1969 — PROLENE<sup>®</sup> Polypropylene Suture
1969 — PROLENE® Polypropylene Suture
The first synthetic sterile suture, PROLENE® Polypropylene Suture is used in cardiac bypass surgery for its strength, secure knotting and biocompatibility.
1978 — PROXIMATE<sup>®</sup> Disposable Skin Stapler
1978 — PROXIMATE® Disposable Skin Stapler
This game-changing skin stapler introduced disposable instruments to the OR. The success of disposable PROXIMATE opened the door to new innovations for open and minimally invasive procedures.
1979 — Coated VICRYL<sup>®</sup> (polyglactin 910) Suture
1979 — Coated VICRYL® (polyglactin 910) Suture
Used by surgeons around the world today for general surgery use, Coated VICRYL® (polyglactin 910) Suture balances the surgeon’s need for slide with knot security in achieving reliable approximation and closure.
1988 —Laparoscopic Cholecystectomy
1988 —Laparoscopic Cholecystectomy
First Laparoscopic Cholecystectomy and development of Minimally Invasive solutions
1993 — ETHICON ENDO-SURGERY
1993 — Ethicon Endo-Surgery
Founded in Ohio, Ethicon Endo-Surgery brought surgical technologies and solutions including staplers, energy devices and trocars.
1995 — Telesurgery
1995 — Telesurgery
Our pioneering live telesurgery, Dr. J. Barry McKernan performed a laparoscopic cholecystectomy at the American College of Surgeons’ annual meeting introduced clinicians to the possibilities of distance learning.
1998 — DERMABOND<sup>®</sup> Topical Skin Adhesive
1998 — DERMABOND® Topical Skin Adhesive
The first FDA-approved topical skin adhesive in the U.S., DERMABOND® Topical Skin Adhesive paved the way for replacing sutures with a new generation of skin closure solutions25,26
1998 — HARMONIC<sup>®</sup> Scalpel Shears
1998 — HARMONIC® Shears
Our launch of the first 5mm HARMONIC® shears allowed surgeons for the first time to dissect, cut and coagulate with one ultrasonic energy device with minimal lateral thermal damage.
2000 — Fighting Obesity
2000 — Fighting Obesity
Committed to shaping the future of surgery in the fight against obesity and metabolic diseases and helping to elevate the standard of care through research and evidence, best-in-class education and training, innovative products and expanding patient access to care.
2003 — Coated VICRYL<sup>®</sup> Plus Antibacterial (polyglactin 910) sutures
2003 — PLUS Sutures
The first commercially available antibacterial suture, Coated VICRYL® Plus Antibacterial (polyglactin 910) Suture broke new ground in addressing a known risk factor for surgical-site infections (SSI), bacterial colonization of the suture.27
2011 — ECHELON FLEX™ Powered ENDOPATH<sup>®</sup> Stapler
2011 — ECHELON FLEX™ Powered ENDOPATH® Stapler
This first powered endocutter with system-wide compression and stability helped to fuel the revolution to minimally invasive approaches. Less unwanted movement of the tip offered the potential for reduced trauma to vital structures, even in thick tissue and at awkward angles.
2015 — VERB Surgical Partnership
2015 — VERB Surgical Partnership
Verb Surgical, founded in 2015, is developing a digital surgery platform built with technology from Verily (formerly Google Life Sciences) and Ethicon Endo-Surgery, Inc. Verb’s platform will include robotics, visualization, advanced instrumentation, data analytics, and connectivity.
2016 — NEUWAVE Medical Acquisition
2016 — NEUWAVE Medical Acquisition
Ethicon acquires NeuWave Medical, Inc., a company that manufactures and markets minimally invasive soft-tissue microwave ablation systems. This acquisition is consistent with the strategy of advancing innovation and investing in areas of unmet medical needs such as surgical oncology.
2017 — MEGADYNE Acquisition
2017 — MEGADYNE Acquisition
The acquisition of Megadyne’s innovative portfolio of electrosurgical tools represents a major step forward in Ethicon’s goal to deliver the most comprehensive suite of intelligent energy solutions that enhance precision and efficiency in the operating room.
Ethicon Bariatric Resources
Ethicon provides a comprehensive portfolio of materials designed to power transformations by supporting your engagements with healthcare professionals and patients at every stage of their journey, from making the decision to have surgery, to sustaining a healthy lifestyle post-operatively.
Peer-Reviewed Evidence in Thoracic Surgery
Your Choice of Stapler Matters
We recently completed peer-reviewed studies, which allow us to share compelling evidence that ECHELON FLEX™ Powered Staplers have been associated with improved clinical and economic outcomes compared to Medtronic non-powered staplers.3
Knot your average suture
Knot your average suture
Get more with STRATAFIX™ Knotless Tissue Control Devices
Traditional suturing techniques can lead to knot-related complications. STRATAFIX™ provides more efficiency and consistency with no need to tie knots, more strength†† and security than traditional sutures, and Plus Antibacterial Technology. Why Knot? When you can STRATAFIX™.4-12
†† Refers to STRATAFIX Symmetric PDS Plus Device only.
Always Prepared
One family. 5 products. Trusted for 50+ years.13-16
Trust the SURGICEL® Family of Absorbable Hemostats for every continuous oozing bleeding situation.
SURGIFLO®. Fully Stocked.
SURGIFLO® Hemostatic Matrix Kitis back with a strengthened supply chain
The recent supply interruption of SURGIFLO® is over—it is back and ready to stop difficult-to-access bleeding situations.
Health Authorities Recommended
The use of triclosan-coated sutures for surgical site infection (SSI) prevention is now recommended by three globally recognized health authorities: Centers for Disease Control and Prevention (CDC),17** World Health Organization (WHO)18** and American College of Surgeons & Surgical Infection Society (ACS & SIS).19**
** The CDC, WHO, and ACS/SIS guidelines on reducing the risk of surgical site infections are general to triclosan-coated sutures and are not specific to any one brand.
Your closure is their beginning
Patient website now available for DERMABOND® Prineo Skin Closure System. Direct your patients to PrineoForPatients.com today.
VISTASEAL™ Fibrin Sealant
VISTASEAL™ Fibrin Sealant
VISTASEAL™ Fibrin Sealant (Human) mimics the clot formation process and forms a rapid, adherent, and durable clot regardless of the patient’s coagulation profile.1,2
ECHELON FLEX™ GST System
ECHELON FLEX™ GST System
The ECHELON FLEX GST System‡ controls tissue movement to enable you to transect as you intend even on the most challenging tissue.
HARMONIC<sup>®</sup> HD 1000i Shears
HARMONIC® HD 1000i Shears
HARMONIC HD 1000i Shears offers a seamless combination of unmatched precision, unparalleled strength, and optimal efficiency.
ECHELON CIRCULAR™ Powered Stapler
ECHELON CIRCULAR™ Powered Stapler
The ECHELON CIRCULAR Powered Stapler is designed to reduce leaks without compromising perfusion—resulting in 61% fewer leaks at the staple line compared to the Medtronic DST Series™ EEA™ Stapler.§
STRATAFIX™ Spiral Knotless Tissue Control Device
STRATAFIX™ Spiral Knotless Tissue Control Device
STRATAFIX Spiral & Spiral Plus Knotless Tissue Control Devices offer a broad range of unidirectional and bidirectional devices, offers the smooth glide of a traditional suture.20-24
News & Events
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References
* Based on number of set-up steps and thawing time required for VISTASEAL™ Dual Applicator vs competition.
‡ System components include ECHELON FLEX™ Powered Plus Stapler and ECHELON ENDOPATH™ Reloads with Gripping Surface Technology.
§ 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. Bjelovic M, Ayguasonosa J, Kim RD, et al. A prospective, randomized, phase III study to evaluate the eicacy and safety of fibrin sealant Grifols as an adjunct to hemostasis as compared to
cellulose sheets in hepatic surgery resections. J Gastrointest Surg. 2018. 22:1939-1949.
2. VISTASEAL™ Fibrin Sealant (Human). [Highlights of Prescribing Information] Instituto Grifols, S.A. 2018.
3. 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.
4. Sissener T. Suture patterns. Com Anim. 2006;11:14-19.
5. Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007;21(10):1175-1178.
6. Vakil JJ, O'Reilly MP, Sutter EG, Mears SC, Belko SM, Khanuja HS. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713.
7. Nonnenman H. 100326296: Time zero tissue holding - Competitive claims comparisons for STRATAFIX Knotless Tissue Control Devices vs various products. 2015. Ethicon, Inc.
8. Levine BR, Ting N, Della Valle CJ. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopedics. 2011;34(9):e473-e475. doi: 10.3928/01477447-20110714-35.
9. Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic myomectomy: evaluation of perioperative outcomes, safety, and efficacy. J Minim Invasive Gynecol. 2011;18(1):92-95.
10. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167.
11. Ming X, Rothenburger S, Yang D. In vitro antibacterial efficacy of Monocryl Plus Antibacterial Suture (poliglecaprone 25 with triclosan). Surg Infect (Larchmt). 2007;8(2):201-207.
12. 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.
13. US Market Share Report, October 2016. Ethicon, Inc.
14. SURGICEL® Technical Report, 2018. Ethicon, Inc.
15. Hong YM, Loughlin KR. The use of hemostatic agents and sealants in urology. J Urol. 2006;176(6 Pt 1):2367-2374.
16. SURGICEL® Absorbable Hemostat. Full Prescribing Information. Ethicon, Inc.
17. 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.
18. WHO Global Guidelines for the Prevention of Surgical Site Infection, 2016.
19. 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.
20. Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007;21(10):1175-1178.
21. Vakil JJ, O’Reilly MP, Sutter EG, Mears SC, Belkoff SM, Khanuja HS. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J Arthroplasty. 2011;26(5):710-713.
22. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167.
23. Levine BR, Ting N, Della Valle CJ. Use of a barbed suture in the closure of hip and knee arthroplasty wounds. Orthopedics. 2011;34(9):e473-e475. doi: 10.3928/01477447-20110714-35.
24. Einarsson JI, Chavan NR, Suzuki Y, Jonsdottir G, Vellinga TT, Greenberg JA. Use of bidirectional barbed suture in laparoscopic myomectomy: evaluation of perioperative outcomes, safety, and efficacy. J Minim Invasive Gynecol. 2011;18 (1):92-95.
25. P960052B.
26. Data on File. Keplinger 07PD0748. Protocol investigation of the comparison of PRINEO with conventional wound closure techniques.
27. Rothenburger S, Spangler D, Bhende S, Burkley D. In vitro antimicrobial evaluation of coated Vicryl Plus Antibacterial Suture (coated polyglactin 910 with triclosan) using zone of inhibition assays. Surg Infect. 2002;3(suppl):S79-S87
VISTASEAL™ Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION
INDICATION
VISTASEAL™ is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.
CONTRAINDICATIONS
Do not inject directly into the circulatory system.
Do not use for the treatment of severe or brisk arterial bleeding.
Do not use in patients with history of anaphylaxis or severe systemic reactions to human blood products.
Do not use VISTASEAL for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved.
WARNINGS AND PRECAUTIONS
Thromboembolic events may occur if VISTASEAL is administered intravascularly.
Only spray VISTASEAL if it is possible to accurately judge the distance from the spray tip to the tissue surface.
Hypersensitivity reactions can occur.
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.
ADVERSE REACTIONS
The most common adverse reactions (reported in >1% of clinical trial subjects) were nausea and procedural pain.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
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