FDA approves leadless CRT device for heart failure | Heart pump accessories recalled | Implantable IVC sensor shows potential

The WiSE CRT system is approximately the size of a single cooked grain of rice. It works with a patient’s existing implant to provide biventricular pacing. 

The mobile power units of certain HeartMate 3 and HeartMate II LVADs have been experiencing “sudden, unexpected performance issues” such as turning on, off or even restarting with no warning. These issues can potentially be fatal, according to an alert shared by the FDA.

The goal is to measure changes in a patient’s IVC area and collapsibility, which can help anticipate when heart failure events might occur. This first-in-human study included data from the first 50 patients to receive the device. 

Older heart failure patients with no immediate family are especially vulnerable. Additional interventions may be necessary to reach these patients and provide the best care possible.

The positive data were presented as part of a late-breaking clinical trial at ACC.25 in Chicago. One cardiologist on stage for the presentation said these findings will impact the way he manages certain TAVR patients.

Researchers tracked patient outcomes through the use of 15 performance measures related to hypertension, coronary artery disease, heart failure and atrial fibrillation.

Researchers used advanced AI to see if any FDA-approved medications could potentially reverse one of the mutations behind dilated cardiomyopathy. Risedronate, a popular osteoporosis medication, is the one candidate that got the job done.