Jan 9, 2018   SOURCE: PR NewsWire

New Absorbable Adjunctive Hemostat From Ethicon Helps Surgeons Control Disruptive Bleeding More Efficiently

SOMERVILLE, N.J., Jan. 9, 2018 /PRNewswire/ -- Ethicon*, part of the Johnson & Johnson Medical Devices Companies,** announced today the U.S. launch of SURGICEL® POWDER ABSORBABLE HEMOSTAT, a powdered adjunctive hemostat that is designed to help surgeons control disruptive bleeding more efficiently. Disruptive bleeding occurs in more than 60% of open surgical procedures([1]) which drives up health care costs and is associated with high mortality rates.

Although traditional methods of hemostasis benefit patients and reduce hospital costs,([2],[3]) many can be ineffective at controlling disruptive bleeding efficiently.([4]) SURGICEL Powder is designed to address continuous, broad-surface oozing and stop bleeding fast. It can easily be applied across broad surfaces making it well-suited for use in a wide range of surgeries, such as certain gynecologic, oncologic, cardiovascular and general procedures.

The Advantages of SURGICEL Powder

The risk of disruptive bleeding during surgery is increasing due to patient factors including a growing number of comorbidities like diabetes, COPD, and cancer; medications such as anticoagulants and antiplatelets; age and complex surgeries. A U.S. study of more than 1.6 million surgeries showed that almost 30% of patients experienced some kind of complication related to bleeding. That figure rises to more than 47% for cardiac surgeries.([5])

While adjunctive hemostats have many benefits, existing devices can be inefficient on broad surface oozing. SURGICEL Powder spreads across broad surfaces, gets right to the source of bleeding and can stop bleeding fast in just 30 seconds--89% faster than the competition([6][i]). SURGICEL Powder also provides added handling and versatility for a wide range of surgical procedures and delivery is more precise than the competition, so it can be less time consuming for surgeons and minimizes product waste.([7])

When bleeding is controlled, studies show that hospitals can save money, especially in procedures like cardiac revascularization and cardiac valve surgery, where a savings of $9,000 and $13,000 per procedure was seen, according to one study.([8]) Specifically, when adjunctive hemostats are used, up to 40% fewer patients require transfusion,([9-17]) a patient's length of hospital stay is reduced by up to four days,([6],[18],[19] )and readmissions are significantly reduced.([20])

"At Ethicon, we combine our expert knowledge in science and technology to continuously innovate and bring forth solutions that help clinicians provide patients with a better experience in surgery and allow hospitals to make investments that deliver improved clinical and economic outcomes," said Oray Boston, Worldwide Vice President, Biosurgery Platform Leader at Ethicon. "SURGICEL Powder is an example of our continued promise to keep patients and customers at the center of everything we do."

SURGICEL Powder may be used in a wide range of surgeries, particularly those where continuous broad-surface oozing is common, such as certain gynecologic, oncologic, cardiovascular and general procedures. SURGICEL Powder offers bactericidal activity in vitro, against all five of the hospital-acquired pathogens (MRSA, MRSE, VRE, PRSP, E Coli)([21]), is fully absorbable within 7 to 14 days([22]) and contains an aggregate of oxidized regenerated cellulose (ORC) fiber fragments that help control capillary, venous, and small arterial hemorrhages. ORC is the same base material found in all SURGICEL® products.

SURGICEL Powder is built on proven SURGICEL® Absorbable Hemostat technology. The SURGICEL Family of Absorbable Hemostats is backed by more than 50 years of proven safety and efficacy.

To learn more about SURGICEL Powder visit: http://www.ethicon.com/healthcare-professionals/products/biosurgery/surgicel-family-of-absorbable-hemostats/surgicel-powder

About Ethicon

From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues, and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon.

*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. Ethicon, Inc. is the legal manufacturer of the SURGICEL® POWDER ABSORBABLE HEMOSTAT. All other trademarks are the property of their respective owners.

**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, and cardiovascular businesses within Johnson & Johnson's Medical Devices segment.

SURGICEL Powder Absorbable Hemostat Essential Product Information

INDICATIONS
(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.
    --  Should not be used to control hemorrhage from large arteries.
    --  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.

[i] Based on a preclinical animal study

[1] Corral M, Hollmann S, Ferko N, et al. Health and economic consequences of controlled versus uncontrolled surgical bleeding in patients treated with haemostatic agents: a retrospective analysis of the premier perspective database. Poster presented at: Society for the Advancement of Blood Management. 2014 Annual Meeting; September, 2014; Houston, Texas.
[2] Schreiber MA, Neveleff DJ. Achieving Hemostasis with Topical Hemostats: Making Clinically and Economically Appropriate Decisions in the Surgical and Trauma Settings. AORN Journal. 2011;94(5):S1-S20.
[3] S-Factors Faculty Training, May 2015. 032231-150331
[4] Camp MA. Hemostatic agents: a guide to safe practice for perioperative nurses. AORN J. 2014;100(2):131-47.
[5] Stokes ME, Ye X, Shah M, et al. Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC Health Services Research. 2011;11:135-148.
[6] SURGICELTechnical Report, 006321-131114. 2013.
[7] Expression testing - ADAPTIV Document 100293850-1
[8] Corral M, Hollmann S, Ferko N, et al. Health and economic consequences of controlled versus uncontrolled surgical bleeding in patients treated with haemostatic agents: a retrospective analysis of the premier perspective database. Poster presented at: Society for the Advancement of Blood Management. 2014 Annual Meeting; September, 2014; Houston, Texas.
[9] Notarnicola A, Moretti L, Martucci A, Spinarelli A, Tafuri S, Pesce V, Moretti B. Comparative efficacy of different doses of fibrin sealant to reduce bleeding after total knee arthroplasty. Blood Coagul Fibrinolysis.
2012;23(4):278-284.
[10] Levy J, Dutton R, Hemphill J, Shander A, Cooper D, Paidas M, Kessler C, Holcomb J, Lawson J. Multidisciplinary approach to the challenge of hemostasis. Anesth Analg. 2010;110(2):354-364.
[11] Molloy D, Archbold H, Ogonda L, McConway J, Wilson R, Beverland D. Comparison of topical fibrin spray and tranexamic acid on blood loss after total knee replacement: a prospective, randomised controlled trial. J Bone Joint Surg Br. 2010;89(3):306-309.
[12] Sabatini L, Trecci A, Imarisio D, Uslenghi MD, Bianco G, Scagnelli R. Fibrin tissue adhesive reduces postoperative blood loss in total knee arthroplasty. J Orthop Traumatol. 2010;13(3):145-151.
[13] Wang G, Hungerford D, Savory C, Rosenberg A, Mont M, Burks S, Mayers S, Spotnitz W. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial. J Bone Joint Surg Am. 2001;83-A(10):1503-1505.
[14] Randelli F, Banci L, Ragone V, Pavesi M, Randelli G. Effectiveness of fibrin sealant after cementless total hip replacement: a double-blind randomized controlled trial. Int J Immunopathol Pharmacol. 2013;26(1):189-197.
[15] Liu L, Wang Z, Jiang S, Shao B, Liu J, Zhang S, Zhou Y, Zhou Y, Zhang Y. Perioperative allogenenic blood transfusion is associated with worse clinical outcomes for hepatocellular carcinoma: a meta-analysis. PLoS One. 2013;8(5):e64261.
[16] Massin P, Scemama C, Jeanrot C, Boyer P. Does fibrin sealant use in total knee replacement reduce transfusion rates? A non-randomised comparative study. Orthop Traumatol Surg Res. 2012;98 (2):180-185.
[17] Joseph T, Adeosun A, Paes T, Bahal V. Randomised controlled trial to evaluate the efficacy of TachoComb H patches in controlling PTFE suture-hole bleeding. Eur J Vasc Endovasc Surg. 2004;27(5):549-552.
[18] Kluba T, Fiedler K, Kunze B, Ipach I, Suckel A. Fibrin sealants in orthopaedic surgery: practical experiences derived from use of QUIXIL(R) in total knee arthroplasty. Arch Orthop Trauma Surg. 2012;132(8):1147-1152.
[19] Dancey A, Cheema M, Thomas S. A prospective randomized trial of the efficacy of marginal quilting sutures and fibrin sealant in reducing the incidence of seromas in the extended latissimus dorsi donor site. Plast Reconstr Surg. 2010;125(5):1309-1317.
[20] Ye X, Rupnow M, Hammond J, Shah M, Farrelly E. Readmission rates and hospital costs associated with fibrin sealant use among patients undergoing orthopaedic surgery J Orthopaedics. 2012;9(1):e11.
[21] Wang A. Surface Energy/Tension Analysis among ORC Aggregate, ORC Fine Fiber and Arista
[22] Hutchinson RW, George K, Johns D, Craven L, Zhang G, Shnoda P. Hemostatic efficacy and tissue reaction of oxidized regenerated cellulose products. Cellulose. 2012;(e-Pub):DOI 10.1007/s10570-012-9828-8.

© 2018 Ethicon Inc.

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