Ethicon Announces FDA Approval For SURGICEL® Powder Absorbable Hemostat

SOMERVILLE, N.J., June 6, 2017 /PRNewswire/ -- Uncontrolled bleeding during surgery can adversely affect patient outcomes, hospital costs and resources.^1-9 Primary methods of hemostasis alone may be ineffective or impractical,¹⁰ and it is increasingly important that health care professionals are equipped with the right solutions to help achieve hemostasis efficiently. Ethicon,* part of the Johnson & Johnson Medical Devices Companies,** announced today that SURGICEL® POWDER ABSORBABLE HEMOSTAT has received approval from the U.S. Food and Drug Administration. With SURGICEL Powder, surgeons will have a simple and predictable adjunctive hemostatic solution to control continuous oozing on broad or raw surfaces so they can focus on more important issues during surgery.¹¹

Comprised of oxidized regenerated cellulose (ORC)– the same base material found in all SURGICEL® products – this new powder version offers quick adjunctive hemostatic coverage with an easy-to-use applicator. SURGICEL Powder penetrates through oozing blood to quickly stop bleeding at the source and forms clots that stay intact even when the surgical field is irrigated.^12,13

"This new and innovative approach to applying ORC, combined with the proven track record of the SURGICEL® brand, will give surgeons an ideal solution to control oozing bleeding on broad surfaces during surgeries," says Oray Boston, Worldwide Vice President, Biosurgery Platform Leader at Ethicon.

For more than 55 years, SURGICEL® has consistently provided safe and effective adjunctive hemostasis, in combination with bioabsorbability and bactericidal properties. With this latest innovation, Ethicon is providing surgeons added handling and versatility in a wide range of surgical procedures. This launch will mark Ethicon as a strong competitor in the growing hemostatic powder market.

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 adjunctive hemostats and our commitment to treating 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, orthopaedics, and cardiovascular businesses within Johnson & Johnson's Medical Devices segment.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding a new product. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, Inc., its affiliated companies and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition in the hemostatic market; changes to applicable laws and regulations, including global health care reforms; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under "Item 1A. Risk Factors," its most recently filed Quarterly Report on Form 10-Q, including under the caption "Cautionary Note Regarding Forward-Looking Statements," and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Ethicon, its affiliates and Johnson & Johnson do not undertake to update any forward-looking statement as a result of new information or future events or developments.

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.

¹ Shippert R (2005) A study of time-dependent operating room fees and how to save $100 000 by using time-saving products. The American Journal of Cosmetic Surgery 22 (1):25-34.
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⁶ Dasta JF, McLaughlin TP, Mody SH, Piech CT (2005) Daily cost of an intensive care unit day: the contribution of mechanical ventilation. Crit Care Med 33 (6):1266-1271.
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⁸ Toner RW, Pizzi L, Leas B, Ballas SK, Quigley A, Goldfarb NI (2011) Costs to hospitals of acquiring and processing blood in the US: a survey of hospital-based blood banks and transfusion services. Appl Health Econ Health Policy 9 (1):29-37.
⁹ Zimlichman E, Henderson D, Tamir O, Franz C, Song P, Yamin CK, Keohane C, Denham CR, Bates DW (2013) Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med 173 (22):2039-2046.
¹⁰ SURGICEL® Powder Absorbable Hemostat, Instructions for Use. Ethicon, Inc.
¹¹ Data on file. Ethicon, Inc. SURGICEL® Powder versus SURGICEL® Original. Final Report, PSE Accession No. 15-0061, Project No. 16438
¹² Data on file. Ethicon, Inc. Surface energy/tension analysis among ORC Aggregate, ORC Fine Fiber, and Arista – Project PIXIE.
¹³ Data on file. Ethicon, Inc. SURGICEL® Powder versus ARISTA™ AH. Final Report, PSE Accession No. 15-0120, Project No. 16438.

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SOURCE Ethicon