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…
ASA annual meeting highlights top 10 risks of providing anesthesia in ambulatory setting
Editor's Note There are certain patients and clinical situations that may require anesthesiologists to say no to performing surgery in the outpatient/ambulatory setting, Anesthesiology News April 4 reports. At the 2023 annual meeting of the American Society of Anesthesiologists (ASA), BobbieJean Sweitzer, MD, a professor of medical education at the…
Bioelectric mesh could help track cardiac disease
Editor's Note Although cardiac disease is the leading cause of human morbidity and mortality globally, the complexity of cardiac tissues makes monitoring difficult. To address this issue, a team from University of Massachusetts Amherst and MIT has created a bioelectronic mesh system that can measure movement of cells in cardiac…
Transcatheter therapy system becomes first to earn FDA approval for treating tricuspid regurgitation
Editor's Note Patients with severe cases of tricuspid regurgitation (in which a critical heart valve fails to close properly) now have a new treatment option thanks to the recent US Food and Drug Administration (FDA) approval of the ENVOQUE tricuspid valve replacement system, according to a February 2 press release…
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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