Edwards Lifesciences sent a formal request to CMS in February after its Evoque TTVR device gained FDA approval. The agency is now accepting public comments for 30 days.

The self-expanding device is now available in more than 20 countries and received CE mark approval back in 2020. However, it has not yet been approved by the U.S. Food and Drug Administration for use in the United States.

BAV patients are often excluded from TAVR trials, creating uncertainty about the best way to treat that population when aortic valve replacement is required. To learn more, researchers tracked CMS data from 2018 to 2022, presenting their findings in The Annals of Thoracic Surgery.

After the significant success of Shockwave Medical's IVL therapy to break up heavily calcified vessels without trauma, there are now several companies working on their own IVL devices. 

SCAI President James Hermiller, MD, recently outlined the key achievements for 2024, including creation of the first interventional cardiology match program, successful advocacy and efforts to increase women in the field.

While the technology and techniques associated with TAVR have advanced over the years, treating patients who present with baseline atrial fibrillation is still associated with certain risks.

Back in 2019, the FDA issued a warning about the use of paclitaxel-coated devices when treating peripheral artery disease. The agency took back that warning in 2023, but it appears to have made a significant impact on patient care. 

Newer balloon-expandable TAVR valves are associated with much better outcomes for patients presenting with both severe AS and severe MS than older models.