Medtronic has secured CE Mark approval for its TYRX absorbable antibacterial envelope, which covers an implantable cardiac device and reduces surgical-site infections.
The efficacy of the previous generation, non-absorbable TYRX Antibacterial Envelope has been shown in three published studies, with new six-month follow-up data from the CITADEL/CENTURION trial.
The company said that six months after implantation, patients who received a single or dual-chamber implantable cardioverter-defibrillator (ICD) or cardiac resynchronisation therapy (CRT) replacement device with a TYRX Antibacterial Envelope experienced lower infection rates compared with a group of patients implanted without the envelope.
According to the trial, infection occurred in 0.2% of patients who received the envelope during an ICD or CRT implant, compared with 1.9% of patients who did not receive the envelope.
In addition, the rate of device mechanical complications was low (4%) in patients who received the envelope.
The multi-centre CITADEL/CENTURION trial included 55 sites in the US that prospectively treated over 1,000 patients undergoing an ICD or CRT replacement with the TYRX Antibacterial Envelope.
Primary endpoints of the trial were major infection (involving any site other than skin or subcutaneous tissue of the incision or endocarditis) and device mechanical complication.
Sahlgrenska University Hospital professor Charles Kennergren said: "The TYRX envelope seems to offer physicians a simple, yet highly effective method of reducing surgical-site infections, particularly among those high-risk patients who are undergoing a repeat procedure.
"We have high expectations for this novel product, both in terms of reducing infection rates as well as avoiding device migrations."
Currently approved for use in the US, Canada and Israel, 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 senior vice-president and cardiac rhythm and heart failure business president John Liddicoat said: "While the risk of infection is low for most patients receiving an implantable device, the TYRX envelope offers an extra layer of protection.
"The TYRX envelope provides physicians with a proven solution to make implantable device procedures safer for their patients."