USFDA allows TYRX to sell antibacterial envelope for use with pacemakers

9 July 2013 (Last Updated July 9th, 2013 18:30)

US-based TYRX has secured clearance from the US Food and Drug Administration (FDA) to sell its AIGISRx R, a bioresorbable and antibacterial mesh envelope that can be used with pacemakers and implantable cardioverter defibrillators (ICDs).

TYRX has secured clearance from the US Food and Drug Administration (FDA) to sell its AIGISRx R, a bioresorbable and antibacterial mesh envelope that can be used with pacemakers and implantable cardioverter defibrillators (ICDs).

Health Canada, the Canadian regulatory agency, gave approval to the AIGISRx R in January this year.

AIGISRx R is designed to securely hold cardiac implantable electronic devices (CIEDs) in place in order to offer a stable environment when the device is implanted in the body.

AIGISRx R contains rifampin and minocycline, two antimicrobial agents.

Released locally into the tissue, these agents help to reduce surgical site infections (SSIs) associated with CIED implantation.

The company claimed that several studies have indicated that in patients who are at high-risk of device infection, CIED implantation with the AIGISRx R reduces such infections in the range of 70%-100%, compared to those who did not receive the antibacterial mesh envelope.

In the last few decades, cardiac device infections have grown significantly and in the US alone, over 500,000 CIED implantations are done in a year.

Following the CIED implantation surgeries, patients suffering with surgical site infections on average spend two additional weeks in the hospital and undergo surgical procedures again to get treated for the infection.

Besides additional treatment costs, patients experience rise in morbidity and mortality, with one-year mortality rates being in the range of 26.5%-35.1%, and three-year mortality by up to 50%.

TYRX president and CEO Robert White said that 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 with the added benefit of being fully resorbable.

"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," White added.