Medtronic (NYSE:MDT) said today that it’s launching a new clinical trial to evaluate the anti-bacterial cardiac implant envelope it bought along with Tyrx for $160 million last year.
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.
Tyrx won 510(k) clearance from the FDA in 2013 and a CE Mark in the European Union in September 2014. Medtronic paid $160 million for Tyrx early last year.
Today Fridley, Minn.-based Medtronic said its roughly 7,000-patient Wrap Infection trial is designed to compare the rate of major infection in patients with cardiac implantable electronic devices at 12 months with patients treated without using the envelope. Although only 3% of CIED patients develop infections, the Centers for Medicare & Medicaid Services estimates that the average cost to treat each infection is about $72,000, according to a press release.
The study is also primed to evaluate the consequent healthcare costs for each arm of the trial, according to the release.
"Even though the risk of major infection is low for patients receiving implantable cardiac electronic devices, the Tyrx envelope offers an added layer of protection for patients at increased risk of infection," tachycardia general manager Dr. Marshall Stanton said in prepared remarks. "The Tyrx envelope is designed to be a simple but cost-effective solution to help keep patients safer from major post-procedure infections and mechanical complications."
"This large-scale trial is the first of its kind to evaluate an antibacterial envelope in cardiac device patients who are at risk for infections," added principal investigator Dr. Bruce Wilkoff of the Cleveland Clinic. "It’s important that we continue to find new ways to help reduce infections in patients with implantable cardiac devices, especially for those patients who are having repeat procedures."
