Researchers focused on a relatively young patient population, hoping to learn as much as possible about the surgical valve's safety and effectiveness over an extended period of time. 

The subcutaneous drug, sold under the brand name Amvuttra, joins an ATTR-CM market that already includes Pfizer’s tafamidis (Vyndaqel, Vyndamax) and BridgeBio’s acoramidis (Attruby).

Abbott has received an investigational device exemption from the FDA for a new clinical trial evaluating the safety and effectiveness of using its coronary IVL technology. The trial is expected to enroll up to 335 U.S. patients.

Steven Bolling, MD, noted that tricuspid treatments have been linked to consistent benefits in terms of quality of life. However, he said, finding clear improvements in clinical outcomes has been more challenging.

The drug in question, ataciguat, could help heart patients avoid aortic valve replacement—or at least put it off until later in life.

Researchers tracked three years of CMS data to explore how meal-based marketing may influence the habits of general and advanced heart failure cardiologists.

CMS will cover TTVR for the treatment of symptomatic tricuspid regurgitation on a national level. The agency first proposed such a policy in December, taking time to consider public comments before finalizing its decision.

The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.