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HPB surgeons know to expect the unexpected
Bleeding and hemorrhage
Discovering additional lesions intra-operatively
Pancreatic leaks following transection
Reducing the burden of bleeding complications
Bleeding complications are common during liver surgery. Up to 28% of U.S. patients receive a blood transfusion during their hospital stay and >13% will experience a bleeding complication, including intraoperative and post-procedural hemorrhage.1,2
Tissue-sparing approach when new lesions are found
HPB Surgeons estimate that in approximately 1/3 of Liver Resections, new lesions are identified intra-operatively.3 Resecting additional lesions may not be the best option if the lesions are difficult to access or additional resection would cause unnecessary risk due to underlying co-morbidities.
Optimizing transection in distal pancreatectomy
Pancreatic fistula is the most common major complication occurring after distal pancreatectomy, ranging in frequency from 5% - 40%.4 Surgical staplers are commonly used to transect the pancreatic body and tail, but pancreatic tissue has unique characteristics.
Education tailored to you
Our educational programs are designed to get you back on track when you face obstacles during HPB surgery. Ethicon offers a variety of on-demand, digital and in-person learning experiences to train on safe and effective use of company products.
* vs. Pringle Maneuver in a prospective randomized controlled trial comparing Pringle Maneuver (n=80) vs. liver resection with Harmonic scalpel (n=80).
† Ex-vivo data available in probe Instructions For Use. See PL-000006, PL-000009, PL-000026, PL-000050, PL-000239, PL-000240 and PL000243.
‡ Challenging tissue—thick, fragile, and varying thickness and density
1. Project Harlow HPB Multivariate Analyses. Ethicon Inc.
2. GHEMA meta-analysis of multiple studies. Evidence Review of complications including transfusion rates by country: China 41.0%, Japan 40.1%, United States 28.2%.
3. Ablation in liver surgery KOL Interview. Ethicon internal market research. 2019
4. Okano, K et al, A simple and safe pancreas transection using a stapling device for a distal pancreatectomy, J Hepatobiliary Pancreat Surg (2008) 15:353–358, DOI 10.1007/s00534-008-1328-8
5. 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;45:127–137.
6. 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. 22:1939–1949.
7. Hunt BJ. Bleeding and coagulapathies in critical care. 2014. N Engl J Med;370:847‐859.
8. Ethicon, Inc. VOC Final Report (J. Helms)
9. Hanyong S et al. A prospective randomized controlled trial: comparison of two different methods of hepatectomy. EJSO 2015; 41:243‐248.
10. 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.
VISTASEAL™ Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION
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.
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.
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.
SURGICEL Essential Product Information
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.
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).
“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.