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EVICEL(TM) Fibrin Sealant (Human) Approved For General Hemostasis In Surgery
ETHICON, INC. announced
that the U.S. Food and Drug Administration has granted an expanded
indication for EVICEL(TM) Fibrin Sealant (Human). The product is the first
fibrin sealant to be indicated as an adjunct to hemostasis for use in
patients undergoing surgery, when control of bleeding by standard surgical
techniques is ineffective or impractical.
EVICEL(TM) is the only all-human plasma-derived fibrin sealant
commercially available in the U.S. It does not contain aprotinin, which has
been associated with adverse health effects. EVICEL(TM) is easy to use and
readily available for time-sensitive needs in the operating room. The
product is sold as a frozen liquid and requires less than one minute
preparation time after thawing.
"In surgery, the success of the procedure can sometimes depend upon the
surgeon's ability to control blood loss quickly and effectively," said R.
Clement Darling III, M.D., head of the Division of Vascular Surgery at
Albany Medical Center. "EVICEL(TM) has become an important element of
hemostasis in many liver and vascular procedures. The expansion of its
indication to general surgery will bring the benefits of this product to
more surgeons and their patients," added Dr. Darling.
EVICEL(TM) is contraindicated in individuals known to have anaphylactic
or severe systemic reaction to human blood products. As with all
plasma-derived products, the risk of transmitting infectious agents cannot
be completely eliminated. EVICEL(TM) should not be injected directly into
the circulatory system or used for the treatment of severe or brisk
arterial bleeding. Anaphylactic reactions may occur. No adverse events of
this type were reported during the conduction of the clinical trials.
EVICEL(TM) was developed by ETHICON, INC. in collaboration with OMRIX
Biopharmaceuticals.
About ETHICON, INC.
ETHICON, INC., a Johnson & Johnson company, is a global medical device
company that develops and markets surgical products for use in general
surgery, wound management and women's health & urology. Johnson & Johnson
Wound Management, a division of ETHICON, INC., offers a complete portfolio
of topical and advanced hemostatic products including SURGICEL(R)
Absorbable Hemostats, SURGIFOAM Absorbable Gelatin Sponge, EVICEL(TM)
Fibrin Sealant (Human), and SURGIFLO Hemostatic Matrix with FlexTip. For
more information about ETHICON, INC., please visit http://www.ethicon.com.
ETHICON, INC
http://www.ethicon.com
EVICEL (TM) fibrinei Sealant (umane) aprobat pentru General Hemostasis În Chirurgie - EVICEL(TM) Fibrin Sealant (Human) Approved For General Hemostasis In Surgery - articole medicale engleza - startsanatate