Surgeons implant first medically suspended heart pump in US
Editor's Note Cardiothoracic surgeons at Emory University Hospital have conducted the first US implantation of the BrioVAD System, a new ventricular assist device (VAD) from BrioHealth Solutions, Cardiovascular Business News reported November 25. According to the article, the BrioVAD System features a magnetically suspended, hemocompatible pump designed to minimize adverse…
Alternative to mitral valve surgery shows promise, but research criticized
Editor's Note Although data suggest transcatheter edge-to-edge repair (TEER) using the MitraClip device may offer similar outcomes to mitral valve surgery in patients with heart failure and functional mitral regurgitation (FMR), experts have criticized the research, TCT MD reported September 1. Presented at the recent European Society of Cardiology (ESC)…
FDA announces Class 1 recalls for ventilators, LVAS monitors
Editor's Note The US Food and Drug Administration has announced class 1 recalls—the most severe category indicating risk of serious injury or death—for Abbot Medical’s HeartMate System Monitor and Philips Respironics OmniLab Advanced+ (OLA+) ventilator. According to the agency’s June 28 report, the recall of the HeartMate System Monitor, part…
Heart pump recall, lack of donor organs create concern for heart failure patients
Editor's Note The lack of available hearts for transplantation combined with the recent recall of Abbott’s HeartMate 3 left ventricular assist device (LVAD) “makes the current therapy landscape for heart failure much more dire,” according to a May 20 report in Medical Device Network. The recall of the device, which…
FDA announces class 1 recalls for heart devices, ventilators
Editor's Note The US Food and Drug Administration (FDA) has classified recalls of Abbot’s HeartMate 3 Left Ventricular Assist System (LVAS) implant kits and Phillips Respironics' Trilogy Evo ventilators as class 1, the most serious category indicating risk of serious injury or death. Used while waiting for recovery, a transplant,…
FDA Class 1 recall renews concern about historically problematic heart pumps
The US Food & Drug Administration (FDA) announced a Class 1 recall on Monday for Abbott/Thoratec Corp.’s HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due due to biological material buildup obstructing the devices. According to an April 16 CBS News report, surgeons first noticed problems with the…
VAD implant requirement reinstated
Editor's Note The Joint Commission, on April 26, announced that the Centers for Medicare & Medicaid Services (CMS) requirement to count the volume of ventricular assist device (VAD) implants by surgeons will be reinstated on May 11. CMS stopped this requirement during the COVID-19 public health emergency.
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