A randomized trial evaluating vitamin K therapy with aspirin or placebo with a left ventricular assist device shows avoiding aspirin reduced bleeding without increasing thrombotic risk.
The FDA says medical device manufacturer Abiomed has voluntarily recalled labeling that s short on safety information for one model in its line of circulatory-assist pumps.
The updated indication tightens the description of eligible patients on the basis of post-approval study results but in line with premarket study entry criteria.
The controller driveline boot cover of the HVAD system may harden over time, which could delay access to the driveline connector, potentially leading to patient harm, a recall notice says.