The TYRX device has been developed to safely hold a percutaneous driveline in patients receiving a ventricular assist device
Medtronic has secured FDA breakthrough device status for TYRX driveline wrap device. (Credit: Medtronic)
Medtronic has secured breakthrough device status from the US Food and Drug Administration (FDA) for its TYRX absorbable antibacterial driveline wrap device.
The TYRX device has been developed to safely hold a percutaneous driveline in patients securing a ventricular assist device (VAD).
The driveline, a crucial component of VAD systems, links the implanted heart pump to an external controller that is supported by an AC or DC adapter, or external batteries.
The pump is said to surge the amount of blood, which circulates across the body in patients with advanced heart failure.
Medtronic aims to leverage its TYRX technology platform to minimise driveline complications
Medtronic is planning to leverage its TYRX technology platform to minimise driveline complications.
The TYRX technology platform is presently used in the TYRX absorbable antibacterial envelope, which is produced using a multifilament, knitted absorbable mesh and releases antimicrobial agents, minocycline and rifampin over a minimum of seven days.
The device, which will be fully absorbed by the body in around nine weeks after implantation, stabilises a cardiac implantable electronic device (CIED) such as a pacemaker or implantable defibrillator or an implanted neurostimulator.
According to the company, the TYRX driveline wrap device is in early-stage research and development and not available for sale in any part of the world.
Earlier this month, Medtronic secured approval from the FDA to begin an early feasibility study (EFS) of the Intrepid transcatheter tricuspid valve replacement (TTVR) system to treat patients with severe and symptomatic tricuspid regurgitation.