Patients experiencing advanced heart failure received good news last week—the U.S. Food and Drug Administration (FDA) approved Medtronic’s TYRX device, which secures a percutaneous driveline in patients that require a ventricular assist device (VAD).
These devices electromechanically assist circulation within the heart and can be used to either fully or partially supplement the function of a failing heart. Patients may use VADs as a short-term recovery solution after a major heart attack, or can use them for months, or even years, to ease the suffering associated with advanced heart failure.
Headquartered in Dublin, Ireland, Medtronics is a global leader in medical technologies and solutions, employing more than 90,000 people worldwide, and serving medical professionals and patients in over 150 countries. Its Tyrx Absorbable Antibacterial Driveline Wrap is made of absorbable mesh and releases minocycline and rifampin, antimicrobials that reduce infections post operation. The company’s previously approved Tyrx Absorbable Antibacterial Envelope, which is made of the same mesh, was reported to reduce major infections by 40% in patients who received implanted electronic devices in their hearts.
“Breakthrough” status was designed to help patients gain access to new technologies that could have immediate results and extend and improve their quality of life. Breakthrough status is most frequently given to devices that treat or help people live with chronic or life-threatening conditions that require immediate action.
The current device can be fully absorbed by the body after a period of nine weeks, after it helps stabilize implanted devices like pacemakers and implantable defibrillators. It is currently still under development and will not be available for an undisclosed period of time.
During the COVID-19 pandemic, it is even more important that patients entering the hospital for non-coronavirus-related reasons are able to leave the hospital quickly and safely. TYRX devices generally target populations that are already at the highest risk for experiencing severe complications of the COVID-19 virus—the elderly and those with underlying conditions. With the antimicrobial absorbable mesh, cardiac patients will be able to leave the hospital soon after surgery and will not have to come in for as many follow-ups.