US-based Medtronic has obtained CE mark approval for its TYRX Absorbable Antibacterial Envelope, which covers an implantable cardiac device and reduces surgical-site infections.
The envelope has been designed to cover a cardiac implantable electronic device (CIED) such as pacemaker and ICD or CRT device.
It releases rifampin and minocycline at the surgical site, which helps in preventing infection.
Medtronic said that the envelope stabilizes the CIED, then dissolves and is fully absorbed in around nine weeks after implantation.
Medtronic senior vice-president and cardiac rhythm and heart failure business president John Liddicoat said the TYRX envelope offers an extra layer of protection, while the risk of infection is low for most patients receiving an implantable device.
"The TYRX envelope provides physicians with a proven solution to make implantable device procedures safer for their patients," Liddicoat added.
Currently, the envelope received approval for use in the US, Canada and Israel. In January 2014, Medtronic acquired US-based TYRX.