Tyrx Introduces Resorbable Envelope to Treat Cardio Implant Infections

Monmouth Junction, N.J.-based Tyrx Inc.’s AigisRx fully resorbable antibacterial envelope has been implanted in a patient for the first time. The procedure was performed at Vanderbilt Heart and Vascular Institute in Nashville, Tenn. by Christopher R. Ellis, M.D. The envelope received U.S Food and Drug Administration clearance in May this year.

“We have been pleased with the performance of the first generation partially-resorbable AigisRx,” said Ellis, cardiac electrophysiologist and assistant professor of medicine at the Vanderbilt Heart and Vascular Institute. “Now with the second generation AigisRx, we have the added benefit of it being fully bioresorbable, which will shorten procedure times required on potential future interventions.”

The device is a fully bioresorbable, antibacterial mesh envelope intended to hold cardiac implantable electronic devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators (ICDs) securely in place to provide a stable environment when implanted in the body. AigisRx is designed in the shape of an envelope or pouch designed to carry or hold the implanted pacemaker and/or ICD when placed into the surgically created “pocket.” The device contains the antimicrobial agents rifampin and minocycline (antobiotics), which are released locally into the tissue to help reduce surgical site infections associated with CIED implantation. According to Tyrx, multiple studies have shown that patients at high risk for CIED infection who are implanted with the AigisRx antibacterial envelope had 70 to 100 percent fewer device infections than similar patients who did who did not receive the AigisRx.

The drugs in question have broad spectrums of use. Minocycline is often used to treat severe acne caused by bacteria. The drug is also known to have anti-inflammatory and neuroprotective properties, so is sometimes used to treat diseases such as Parkinson’s disease or multiple sclerosis. When Rifampin was introduced in 1967, it was a major ingredient in the drug cocktail to treat tuberculosis. With AigisRx, the drugs will primarily be fighting infections such as staphylococci, which are the most common pathogens in both pocket infections and endovascular infections after CIED/ICD implantations. Inflammatory signs at the generator pocket are the most common presentation of an infection occurring soon after the device is implanted.

Vanderbilt Heart and Vascular Institute recently performed a matched cohort study to compare the incidence of CIED infection in patients receiving a CIED with or without an AigisRx antibacterial envelope. After a minimum of 90 days of follow-up, the incidence of CIED infection was significantly lower in the group that received the AigisRx, compared to those that did not (0.4 percent compared to 3 percent). There were 87 percent fewer CIED infections in patients who received the AigisRx, compared to those who did not. The study appeared in Pacing Clinical Electrophysiology this year.

“The AigisRx provides physicians and facilities with a key tool in preventing surgical site infections and in helping to lower the hospital costs associated with them,” said Robert White, Tyrx president and CEO.  “Two recent studies indicate that hospitals can save $102,000 for every 100 high-risk patients that receive the AigisRx antibacterial envelope.”

Tyrx makes implantable combination drug plus device products focused on infection control.