Thoracic Surgery

*Versus leading staplers on the market as of October 2017.

† Approach angles assessed in a virtual CAD environment in the 5th intercostal space.

‡ Compared to the Endo GIA™ Curved Tip Reload with Tri-Staple™ technology. Based on articulation data from IFUs of each device. 

§System components include ECHELON FLEX™ Powered Stapler and ENDOPATH ECHELON™ Reloads with Gripping Surface Technology.

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

1. 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.

2. Data on file. Ethicon, Inc. SURGICEL^® Powder versus Competitive Powdered Hemostats. Final Report, PSE Accession No. 16-0006. Project No. 16438.

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.