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Classified in: Health
Subject: FDA

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

WARNINGS

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.

ADVERSE EVENTS

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.
2 McMenamin P (Web Page) 2009 Registered nurses employment and earning. American Nurses Association. Updated Available from: (http://www.nursingworld.org/MainMenuCategories/Policy-Advocacy/Positions-and-Resolutions/Issue-Briefs/RN-Employment-Earnings.pdf). Accessed Aug. 20, 2014.
3 Farnworth LR, Lemay DE, Wooldridge T, Mabrey JD, Blaschak MJ, DeCoster TA, Wascher DC, Schenck RC, Jr. (2001) A comparison of operative times in arthroscopic ACL reconstruction between orthopaedic faculty and residents: the financial impact of orthopaedic surgical training in the operating room. Iowa Orthop J 21 31-35.
4 The Henry J. Kaiser Family Foundation (Web Page) Hospital Adjusted Expenses per Inpatient Day. Updated 2012. Available from: (http://kff.org/other/state-indicator/expenses-per-inpatient-day/). Accessed Mar. 25 2015.
5 Halpern NA, Pastores SM (2010) Critical care medicine in the United States 2000-2005: an analysis of bed numbers, occupancy rates, payer mix, and costs. Crit Care Med 38 (1):65-71.
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.
7 Kahn JM, Rubenfeld GD, Rohrbach J, Fuchs BD (2008) Cost savings attributable to reductions in intensive care unit length of stay for mechanically ventilated patients. Medical care 46 (12):1226-1233.
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 ARISTAtm AH. Final Report, PSE Accession No. 15-0120, Project No. 16438.

073699-170604

SOURCE Ethicon


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