Evicel™ (in the US) and Quixil® (outside of the US) are
our marketed liquid fibrin sealants used as an adjunct to hemostasis
in surgical procedures. Both products contain a unique Biologically
Active Component, or BAC, which includes a suite of naturally occurring
proteins, not present in other fibrin sealants. We believe this
leads to a clot that has greater elasticity and adherence to tissue.
Evicel™ is approved in the US as an adjunct to hemostasis
for use in patients undergoing surgery when control of bleeding
by standard surgical techniques is ineffective or impractical.
Ease-of-use. Fibrin sealants are used in time-critical
situations and therefore must be easy to use and readily available
for spraying and dripping. Evicel™ and Quixil® are sold
as a frozen liquid and require less than one minute preparation
time in the operating room after thawing. In addition, Evicel™
and Quixil® are transparent, making it easy for the surgeon
to see the underlying surface after the sealant has been applied
to determine whether hemostasis has been achieved.
Efficacy. The naturally occurring suite of proteins in
BAC in Evicel™ and Quixil® results in a clot that has
good adherence to tissue and good elasticity.
Safety. Evicel™ and Quixil® are the first, and
currently the only, commercially available liquid fibrin sealants
products that do not contain animal-derived components, thereby
avoiding the possibility of an adverse reaction associated with
the exposure to bovine proteins contained in other commercially
available fibrin sealants.
- Warning: Quixil® must not be used in contact with CSF or
dura matter.
For further details and warnings, please see full Prescribing Information.
In 2004, Frost & Sullivan awarded the Product Differentiation
Leadership Award to Ethicon as a result of Ethicon's inclusion of
Crosseal™*/Quixil® in its product portfolio. The award
is presented each year to a company that best demonstrates the ability
to develop or advance products with more innovative capabilities
than competing companies and products. According to Frost &
Sullivan, such innovation is expected to significantly contribute
to the industry in terms of product performance and rate of technical
change.
* Crosseal™ has been replaced by Evicel™
in the US.
Evithrom™ Thrombin Topical (Human)
Evithrom™ Thrombin Topical (Human), marketed in the US, is
a blood-clotting protein used to help control bleeding during surgery.
Evithrom™ is the first human thrombin approved since 1954
and is the only product currently licensed. This product is identical
to the thrombin component of our approved and marketed fibrin sealants,
Evicel™/Quixil®. It is derived from human plasma obtained
from carefully screened and tested U.S. donors and has undergone
steps to further reduce the risk for transfusion-transmitted diseases.
We believe that Evithrom™ has several competitive advantages
over other Topical Thrombin's on the market:
Ease-of-use. Thrombin Topical (Human) is used in time-critical
situations and therefore must be easy to use and readily available
for application. Evithrom™ is sold as a frozen liquid and
requires less than one minute preparation time in the operating
room after thawing.
Efficacy. In a clinical trial involving several hundred
subjects, Evithrom™ was found comparable to cattle-derived
thrombin in both safety and effectiveness.
Safety. Evithrom™ is the first, and currently the
only, commercially available Topical Thrombin product that does
not contain animal-derived components, thereby avoiding the possibility
of an adverse reaction associated with the exposure to bovine proteins,
e.g. bovine Thrombin.
On August 28, 2007 we announced the approval of the Biologics License
Application (BLA) for Evithrom™.
For further details and warnings, please see full Prescribing Information.
|
about us
