Another class I recall for HeartWare — this time, for the batteries of the ventricular assist device due to premature power depletion. This is the latest in a series of headaches for the device maker, which has had to recall pump controllers and driveline connectors and has troubles with its manufacturing process. Now the company is being acquired by Medtronic for $1.1 billion.
The HeartWare problems echo a finding that medical devices that win CE Mark in Europe before gaining FDA clearance in the U.S. are almost three times more likely to have subsequent safety alerts and recalls. HeartWare was CE marked in 2009; and FDA approved in 2012.
And speaking of Medtronic, the device giant launched the Beacon Heart Failure Management Service, a tool for daily implantable cardioverter-defibrillator or cardiac resynchronization therapy device data monitoring. When signs point to heart failure events, the service pings healthcare providers for help.
Progressive coronary artery calcification was modestly tied to adverse cardiovascular events in an observational study. Baseline calcification had a stronger association with events, with data from follow-up scans adding no additional prognostic information.
A U.K. woman was hospitalized after getting chest pains at a Rod Stewart concert. She was diagnosed with takotsubo cardiomyopathy, dubbed “broken heart syndrome” because of its association with periods of bereavement. “It is unusual to see it happen when somebody is more likely to be feeling elation at an event such as a live concert,” consultant interventional cardiologist Madhusudhan Varma, MBBS, told the Cumberland News.
Researchers have developed a material that could potentially be developed into a pacemaker “patch” that sits on the surface of the heart, using lower voltages than traditional devices and with the ability to continuously monitor cardiac activity direct from tissue.