Medtronic (NYSE:MDT) said it won CE Mark approval in the European Union for the Tyrx cardiac device envelope it acquired earlier this year and announced its immediate launch in countries that recognize the CE Mark.

The Tyrx envelope is an anti-bacterial mesh pouch used to cover implanted cardiac devices designed to reduce infections at the surgical site by releasing rifampin and minocycline before dissolving roughly 9 weeks after implantation of a pacemaker, ICD or CRT device.

The Tyrx envelope won 510(k) clearance from the FDA in July 2013; Medtronic paid $160 million for Tyrx early this year.

"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," Dr. Charles Kennergren of Sahlgrenska University Hospital in Gothenburg, Sweden, said in prepared remarks. "We have high expectations for this novel product, both in terms of reducing infection rates as well as avoiding device migrations."

"While the risk of infection is low for most patients receiving an implantable device, the Tyrx envelope offers an extra layer of protection," added Medtronic’s cardiac rhythm & heart failure president Dr. John Liddicoat. "The Tyrx envelope provides physicians with a proven solution to make implantable device procedures safer for their patients."