Bariatric Surgery

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Bariatric

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Innovation in the operating room. Ethicon offers a comprehensive portfolio of medical device products for bariatric and metabolic surgery. We relentlessly invest in innovation to provide a comprehensive portfolio of market-leading products.

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References

If you have any questions regarding the tool, please contact ETHICON REIMBURSEMENT SUPPORT SERVICES 1-888-750-1242; [email protected]

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

** The information provided is based on analysis of data aggregated from one or more data sources and does not represent any statement, promise or guarantee by Johnson & Johnson Medical Device Companies (“JJMDC”) concerning costs, clinical outcomes or data accuracy. Always check with your insurance provider regarding up-to-date coverage information.

The information should be carefully considered along with clinical experience, treatment patterns and other factors pertaining to the specific institution or patients. The information being provided is not a substitute for clinical judgment, and neither JJMDC nor any other party involved in the preparation or publication of this information shall be liable to you or others for any decisions made or action taken by you or others in reliance on this information.

A positive coverage policy does not ensure coverage.  It is strongly recommended that the provider reach out to the applicable payer to verify benefits and verify any payer specific requirements for pre-authorization and billing prior to providing any services and filing any claims for payment.

  1. 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.
  2. Eickmann T, Quane E. Total knee arthroplasty closure with barbed sutures. J Knee Surg. 2010;23(3):163-167.
  3. 100326296: Time Zero Tissue Holding - Competitive Claims Comparisons for STRATAFIX™ Knotless Tissue Control Devices vs Various Products. 2015.
  4. 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. 
  5. STAR ASA coverage area test using corium tissue on a 45 degree tilted plane. September 2014. Ethicon, Inc. 
  6. In a 2015 U.S. market research study by Ethicon that surveyed surgeon preference (63.9% Ethicon vs. 24.7% Medtronic) (p<0.001). 

  7. Challenging tissue - thick, fragile, and varying thickness and density

  8. Based on benchtop metrology and porcine comparative studies vs. legacy HARMONIC® and LigaSure™ Maryland devices.

  9. Market share data compiled from Decision Resources Group.

  10. Compared to Harmonic ACE+7 Shears

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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