TYRX Gains FDA Clearance For Resorbable Antibacterial Device Envelope

Article preview from Medtech Insight - August 2013

TYRX Inc. has received FDA clearance for a fully-resorbable version of its antibacterial envelope, used to prevent surgical site infections in patients who receive implantable devices such as ICDs. The resorbable device has important advantages over the previous durable envelope and could substantially boost physician adoption of the company’s technology.

TYRX Gains FDA Clearance For Resorbable Antibacterial Device Envelope

Article preview from Medtech Insight - August 2013

TYRX Inc., which in January 2008 received 501(k) clearance for its AIGISRx Antibacterial Envelope for use with cardiac implantable electronic devices (CIEDs), such as implantable cardioverter defibrillators (ICDs), has now received clearance for its next-generation product: a fully resorbable envelope that adds to the existing benefits of creating a stable device environment and helping to reduce surgical site infections. The first US implantation of the resorbable device occurred in early August at the Vanderbilt University Medical Center’s Vanderbilt Heart and Vascular Institute in Nashville, TN. 

“The envelope no longer remains behind, so later, when the electrophysiologist replaces the battery of a pacemaker, for example, there is no need to explant the envelope or maneuver around the device during the course of the procedure,” says Robert White, president and CEO of TYRX. “There are a lot of physicians who have been reluctant to embrace our technology aggressively because of the extra time required [during follow-up procedures],” White says. “However, over the years, we have heard from numerous doctors that if we can make our device resorb into the body, they will use it on most patients.”

The envelope fully resorbs within 90 days and typically saves the physician five to 10 minutes during any subsequent procedure. Like the durable version, it contains the antimicrobial agents rifampin and minocycline, which the company says are effective against the pathogens responsible for the majority of CIED infections, including methicillin-resistant Staphylococcus aureus (MRSA).

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