The agency warned that any unused devices should be removed from the market and returned to the manufacturer.

Aortic valve replacement is likely inevitable for patients with asymptomatic severe aortic stenosis. Immediately performing TAVR or SAVR, however, may not always be the answer.

Researchers focused on data from nearly 78,000 adults with cardiometabolic disorders, sharing their findings at ACC.25 in Chicago.

"We wanted to ensure that every interventionalist, regardless of location or resources, has access to the best information possible," one co-author said. 

Michael J. Reardon, MD, shared the highly anticipated data with a large audience at ACC.25 in Chicago. Overall, he said, these five-year findings suggest TAVR with a supra-annular, self-expanding valve is a safe and effective alternative to SAVR.

Researchers still think patients should receive an injectable version of semaglutide when possible, but new data out of ACC.25 confirm that an oral formulation of the drug is associated with significant benefits.  

Patients who present with type 2 diabetes and PAD often face substantial mobility issues. According to new data presented at ACC.25, however, treatment with semaglutide could represent a major step forward for this high-risk population.

Etripamil's journey toward FDA approval hit a roadblock. The agency requested additional information on the drug, including a new facility inspection, in a response letter sent to Milestone Pharmaceuticals.