Medtronic Gains FDA Breakthrough Device Designation for Antibacterial Driveline Wrap
Medtronic has received a Breakthrough Device designation from the FDA for its TYRX absorbable antibacterial driveline wrap, a device that holds a percutaneous driveline in place for patients receiving a pacemaker or other ventricular-assist device.
Drivelines extend outside the patient’s body to connect implanted heart pumps to external controllers. The antibacterial driveline wrap helps to protect against bacterial infection by releasing antimicrobial agents over time.
The wrap, which is fully absorbed by the body in approximately nine weeks, stabilizes implantable electronic devices, including pacemakers, defibrillators and neurostimulators.