This is a Class I recall, which means using the devices “may cause serious injuries or death.” The catheter's instructions have been updated to reduce the risk of complications going forward. 

Yes, all-cause cause mortality is higher among TAVR patients with a very low baseline gradient, but the difference is almost entirely due to those patients presenting with more comorbidities. 

The European Society of Cardiology's annual meeting is scheduled for Aug. 25-28, 2023, in Amsterdam.

A few members of the panel did question the device's efficacy and long-term durability. The FDA will now use these findings to make its final decision related to the system's approval. 

Researchers examined data from more than 1,300 procedures, presenting their findings in JACC: Cardiovascular Interventions.

The vote was close, initially ending with a tie, but the panel ultimately decided there were too many questions related to the device's long-term benefits for patients with uncontrolled hypertension.

American Society of Echocardiography (ASE) President Stephen Little, MD, says there will be an increasing need for interventional echocardiographers in the near future.

The four-day event in Amsterdam officially begins on Friday, Aug. 25. Read our sneak preview of some of the conference's key sessions.