TYRX Receives FDA Clearance for Fully Resorbable AIGISRx® R Antibacterial Envelope
MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--
TYRX, Inc. announced today that it has received U.S. Food and Drug
Administration (FDA) clearance to market the Fully Resorbable AIGISRx R
Antibacterial Envelope for use with pacemakers and implantable
cardioverter defibrillators (ICDs). The AIGISRx R Antibacterial Envelope
received approval from Health Canada in January 2013.
AIGISRx R is a fully bioresorbable, antibacterial mesh envelope,
intended to hold CIEDs securely in place in order to provide a stable
environment when implanted in the body. Key to its design, AIGISRx R
contains the antimicrobial agents rifampin and minocycline, which are
released locally into the tissue, to help reduce surgical site
infections (SSIs) associated with CIED implantation. Multiple studies
have shown that in patients at high-risk for device infection, CIED
implantation with the AIGISRx Antibacterial Envelope significantly
reduced device infections by 70% - 100%, compared to patients who did
not receive the AIGISRx.
Over the last couple of decades, the number of cardiac device
infections has risen sharply and out of proportion to the number of
device implantations. With more than 500,000 CIED implantations annually
in the U.S., it is imperative that infections associated with these
types of procedures are avoided to save lives and money, according to
electrophysiologist Dr. Charles Love, Professor of Medicine and the
Director of Cardiac Rhythm Device Services for the Division of
Cardiovascular Medicine at The Ohio State University Wexner Medical
Center. The AIGISRx R provides physicians with a key technology to
prevent surgical site infections following CIED implantation.
Patients with SSIs following CIED procedures spend an average of two
extra weeks in the hospital, undergo repeat surgical procedures to treat
the infection, and cost the facility an average of $72,485.
Additionally, such patients experience significant increases in
morbidity and mortality, with 1-year mortality rates of 26.5 35.1%,
and 3-year mortality of up to 50%, depending on device type.
The AIGISRx R represents the next generation of TYRXs Antibacterial
Envelope technology, providing all of the advantages of the original
AIGISRx, such as device stabilization and infection reduction, but now
with the added benefit of being fully resorbable, commented Robert
White, TYRX President and Chief Executive Officer. Without question,
FDA-clearance is a major milestone for TYRX and cements our leadership
in the effort to reduce surgical site infections following CIED
implantation. Our mission is to make the AIGISRx R a standard-of-care
for all high-risk CIED surgeries where patients are especially
vulnerable to the dire effects of an infection.
TYRX, Inc. commercializes innovative, implantable combination
drug+device products focused on infection control, including the AIGISRx
Antibacterial Envelope, designed to reduce surgical site infections
associated with Cardiac Implantable Electronic Devices (CIEDs). AIGISRx
products contain the antimicrobial agents, rifampin and minocycline,
which have been shown to reduce infection by pathogens responsible for
the majority of CIED infections, including superbugs such as
methicillin-resistant . (MRSA).*
*Data on file at TYRX and published Hansen . 2009; 32(7):898-907.
TYRX, Inc.Robert WhitePresident and Chief Executive Officer732-246-8676info@TYRX.comorFor
Media:Kureczka/Martin AssociatesJoan Kureczka, 415-690-0210Joan@Kureczka-Martin.com
Source: TYRX, Inc.