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.

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.

The care team behind the very first robotic aortic valve replacement and coronary artery bypass surgery has written about the experience in The Annals of Thoracic Surgery. The group discussed the development of the technique, how the patient was chosen for treatment and other key details.