Medtronic has received CE Mark for its TYRX Absorbable Antibacterial Envelope. TYRX (previously called AIGISRx) is a mesh envelope covering implantable cardiac devices such as pacemakers, ICD’s, or CRT devices. After implantation it releases the antibiotics rifampin and minocycline to the surgical site to prevent infection. Furthermore, the envelope stabilizes the device, avoiding device migration. After about a month it starts dissolving and after a little over two months it is completely absorbed.
Impressively, recently released data from the previous generation, non-absorbable version of the TYRX envelope showed infection rates about 90% lower than a historical cohort of patients who were implanted without the envelope. Infection only occurred in 0.2 percent of patients and the rate of device mechanical complications was low (4.0 percent). The TYRX Absorbable Antibacterial Envelope has previously been cleared for use in the United States, Canada and Israel.
Flashbacks: AIGISRx Anti-Bacterial Patch Helps Prevent Post-Surgery Infection in Soft Tissue; TYRX AIGISRx R Resorbable Antibacterial Envelope for Cardiac Implants OK’d by FDA; CanGaroo ECM Envelope Bioscaffold Holds Cardiac Implants, Turns Into Vascularized Tissue
Press release: Medtronic Announces CE Mark and European Launch of TYRX Absorbable Antibacterial Envelope…
Product page: TYRX Absorbable Antibacterial Envelope…