DEERFIELD, Ill., January 30, 2012 - Baxter International Inc.
(NYSE:BAX) announced today that the U.S. Food and Drug
Administration (FDA) has approved TISSEEL [Fibrin Sealant] to
include general hemostasis in surgery when control of bleeding by
standard surgical techniques is ineffective or impractical. TISSEEL
is effective in heparinized patients. TISSEEL mimics the final
stages of the body's own blood clotting cascade, creating a clot
that adheres to the wound surface and helps achieve hemostasis.
"The expanded indication for TISSEEL offers more surgeons an
effective tool for controlling bleeding across a wider variety of
surgical procedures," said Sibu Saha, M.D., Professor of Surgery,
University of Kentucky. "This includes patients who have been
treated with heparin who may have unique treatment challenges,
which was the case for some of the patients involved in Baxter's
clinical trials."
A Phase III clinical study assessed the safety and efficacy of
TISSEEL in peripheral vascular surgery compared with manual
compression, a standard of care, in 140 evaluable patients (70
patients per treatment arm). In the study, TISSEEL was shown
to be statistically significantly better than manual compression in
achieving hemostasis. These study results complement a clinical
data package showing the safety and effectiveness of the use of
TISSEEL as an adjunct to hemostasis.
"TISSEEL and its multiple application devices make it
well-suited for a variety of surgical situations, such as open and
laparoscopic procedures, reinforcing Baxter's commitment to
supporting solutions to the surgical community," said Prof. Hartmut
J. Ehrlich, M.D., vice president of global research and development
in Baxter's BioScience business.
About TISSEEL
TISSEEL is a fibrin sealant indicated for use as an
adjunct to hemostasis in patients undergoing surgery when control
of bleeding by conventional surgical techniques (such as suture,
ligature, and cautery) is ineffective or impractical. TISSEEL
is effective in heparinized patients.
TISSEEL is a fibrin sealant indicated as an adjunct to standard
surgical techniques (such as suture and ligature) to prevent
leakage from colonic anastomoses following the reversal of
temporary colostomies.
Important Risk Information
For Topical Use Only. Do not inject TISSEEL directly into the
circulatory system or into highly vascularized tissue.
Intravascular application of TISSEEL can lead to intravascular
coagulation, may result in life-threatening thromboembolic events
and may increase the likelihood of acute hypersensitivity reactions
in susceptible patients. Exercise caution to minimize the
risk of intravascular application when using TISSEEL in
surgery.
Do not use TISSEEL in individuals with a known hypersensitivity
to aprotinin.
Do not use TISSEEL for the treatment of severe or brisk arterial
or venous bleeding. In these situations, TISSEEL will be washed
away in the flow of blood before hemostasis can be attained.
Hypersensitivity or allergic/anaphylactoid reactions may occur
with the use of TISSEEL. Such reactions may especially be seen if
TISSEEL is applied repeatedly over time or in the same setting, or
if systemic aprotinin has been administered previously.
Aprotonin is known to be associated with anaphylactic reactions.
Even in the case of strict local application of aprotinin, there is
a risk of anaphylactic reactions to aprotinin, particularly in the
case of previous exposure.
Discontinue administration of TISSEEL in the event of
hypersensitivity reactions. Remove remaining product from the
application site.
Air or gas embolism has occurred when fibrin sealant was
administered using pressurized gas. This may occur if a spray
device is used at higher than recommended pressures and in close
proximity to the tissue surface.
When using the EASYSPRAY device, or an equivalent spray device
for open surgical procedures cleared by FDA, TISSEEL must not be
sprayed in enclosed body areas and must be sprayed onto only
visible application sites.
TISSEEL is denatured when exposing to solutions containing
alcohol, iodine or heavy metals. If any of these substances have
been used to clean the wound area, the area must be thoroughly
rinsed before the application of TISSEEL.
Apply TISSEEL as a thin layer by dripping or spraying using
cannula or spray set. Excess clot thickness may negatively
interfere with wound healing.
The safety and effectiveness of TISSEEL used alone or in
combination with biocompatible carriers in neurosurgical procedures
or other surgeries involving confined spaces have not been
evaluated; its use in this setting is not FDA approved.
TISSEEL is made from human plasma. It may carry a risk of
transmitting infectious agents, e.g., viruses, and theoretically,
the Creutzfeldt-Jakob disease (CJD) agent.
Please see full prescribing information at
http://www.baxter.com/downloads/healthcare_professionals/
products/Tisseel_PI.pdf
About Baxter
Baxter International Inc., through its subsidiaries,
develops, manufactures and markets products that save and sustain
the lives of people with hemophilia, immune disorders, infectious
diseases, kidney disease, trauma, and other chronic and acute
medical conditions. As a global, diversified healthcare
company, Baxter applies a unique combination of expertise in
medical devices, pharmaceuticals and biotechnology to create
products that advance patient care worldwide.
SOURCE