Medtronic (NYSE:MDT) announced today that it received FDA breakthrough device designation for its TYRX absorbable antibacterial driveline wrap.
Fridley, Minn.-based Medtronic’s TYRX system is designed to securely hold a percutaneous driveline for patients receiving a ventricular assist device (VAD), according to a news release.
Drivelines connect the implanted heart pump to an external controller powered by an AC or DC adapter or external batteries. They are designed to increase the amount of blood circulating through the body in patients with advanced heart failure, but, as they extend outside the body, they are susceptible to infection.
TYRX is constructed from a multifilament, knitted absorbable mesh and releases antimicrobial agents, minocycline and rifampin, over a minimum of seven days. The platform is fully absorbed by the body about nine weeks following implantation and stabilizes a cardiac implantable electronic device (CIED) or an implanted neurostimulator, Medtronic said.
The platform is still in the early-stage research and development phase and is not commercially available anywhere in the world.