The FDA is reclassifying interventional cardiovascular implant simulation software into the class II (special controls) regulatory category, which will make it easier for the technology to pass regulatory approval. 

Brian Lindman, MD, discusses the tracking of TAVR devices for signs of deterioration and how to assess long-term durability.

The study, published in JACC: Cardiovascular Interventions, focused on data from more than 3,500 TAVR patients. 

The new-look adjustable stents, not yet fully approved by the FDA, can be expanded as a child ages. The hope is that these stents will never need to be replaced.

Gabler, a Texas native, has two decades of experience in the cardiology space, spending the last 11 years with Edwards Lifesciences. He has also previously worked for both Medtronic and Boston Scientific.

Researchers have completed a new analysis of the Evolut Pro and Pro+ devices from Medtronic and the Sapien 3 Ultra devices from Edwards Lifesciences, sharing the results in JACC: Cardiovascular Interventions.

Oversized devices are becoming more common as time goes on, which suggests operators are growing increasingly comfortable with this treatment choice.

The new-look device gained CE mark approval in Europe in 2020, but it has not been approved yet in the United States.