FDA clears fully resorbable AIGISRx R Antibacterial Envelope


On 9 July, the US Food and Drug Administration (FDA) gave clearance to TYRX for its fully resorbable AIGISRx R Antibacterial Envelope for use with pacemakers and implantable cardioverter defibrillators (ICDs).

AIGISRx R is a fully bioresorbable, antibacterial mesh envelope, intended to hold cardiovascular implantable electronic devices securely in place in order to provide a stable environment when implanted in the body. The envelope contains the antimicrobial agents rifampin and minocycline, which are released locally into the tissue, to help reduce surgical site infections associated with device implantation.

Studies have shown that in patients at high-risk for device infection, cardiovascular implantable electronic device 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 cardiovascular implantable electronic device implantations annually in the USA, it is imperative that infections associated with these types of procedures are avoided to save lives and money,” said Charles Love, professor of Medicine and director of Cardiac Rhythm Device Services for the Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center, USA. “The AIGISRx R provides physicians with a key technology to prevent surgical site infecti
ons following device implantation.”

According to a company release, patients with surgical site infections following cardiovascular electronic device implantation 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 US$72,485. Additionally, such patients experience significant increases in morbidity and mortality, with one-year mortality rates of 26.5 – 35.1%, and three-year mortality of up to 50%, depending on device type.

“The AIGISRx R represents the next generation of TYRX’s Antibacterial Envelope technology, providing all of the advantages of the original AIGISRx, such as device stabilisation 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 cardiovascular implantable electronic device procedures. Our mission is to make the AIGISRx R a standard-of-care for all high-risk cardiovascular implantable electronic device surgeries where patients are especially vulnerable to the dire effects of an infection.”

The AIGISRx R Antibacterial Envelope
received approval from Health Canada in January 2013.