Medtronic has received Breakthrough Device Designation status from the US Food and Drug Administration (FDA) for the Tyrx absorbable antibacterial driveline wrap, which is intended to securely hold a percutaneous driveline in patients receiving a ventricular assist device (VAD).
A vital component of VAD systems, the driveline connects the implanted heart pump to an external controller that is powered by an AC or DC adapter, or external batteries. The pump increases the amount of blood that circulates through the body in patients with advanced heart failure. Because the driveline extends outside the body, it is susceptible to infection.
To help reduce driveline complications, Medtronic will leverage its Tyrx technology platform, currently utilised in the Tyrx absorbable antibacterial envelope, which is constructed from a multifilament, knitted absorbable mesh, and releases antimicrobial agents, minocycline and rifampin, over a minimum of seven days. It is fully absorbed by the body approximately nine weeks after implantation, and stabilises a cardiac implantable electronic device (CIED) such as a pacemaker or implantable defibrillator, or an implanted neurostimulator.
The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the programme, the FDA will provide Medtronic with priority review and interactive communication regarding device development, through to commercialization decisions. The Medtronic Tyrx driveline (DL) wrap device is in early-stage research and development, and is not available for sale anywhere in the world.