The instructions for Abbott's Amplatzer Amulet Left Atrial Appendage Occluder now include more details about minimizing the risk of pulmonary artery injury. This a Class II recall, but no devices need to be returned.

Children with congenital heart disease outgrow their replacement valves, requiring repeat open-heart surgeries. The Autus can be expanded using a transcatheter procedure.

A new FDA-approved pulmonary valve should reduce the number of open-heart surgeries children with congenital heart disease require as they grow older. Emile Bacha, MD, explained the importance of this device in a new video interview. 

Certain Sapien M3 TMVR delivery systems have been linked to a risk of malfunctioning in a way that puts patients at risk. The devices included in this early alert should be returned to the manufacturer. 

The next-generation surgical device from Corcym was associated with consistent durability and positive safety data. For example, freedom from structural valve deterioration was seen in 99.7% of patients.

CMS just finalized major updates to its TAVR coverage policies. Could even more change be on the horizon? 

MRI scans have traditionally been used for extracellular volume assessments. That is starting to change, however, as cardiac CT moves beyond its typical focus on the coronary arteries.

The new software from Chicago-based Tempus AI was designed to identify signs of moderate or severe MR. This is the company's second FDA clearance in the last two months.

The new device, designed to perform mitral valve repair in patients with functional MR, was co-invented by cardiologist Samir Kapadia, MD, and surgeon Jose Navia, MD.