TEVAR Device Indications Expanded for All Type B Aortic Dissections

eacts-4The US Food and Drug Administration recently expanded indications for two thoracic endovascular aortic repair (TEVAR) devices for the treatment of all classifications of type B aortic dissections, even though TEVAR’s efficacy had been studied only for type B acute complicated dissections. A session developed by STS and the European Association for Cardio-Thoracic Surgery will examine how this ruling has created a seismic shift in the distal treatment of thoracic aortic disease.

“The FDA usually studies safety and efficacy before approval. In this particular case, it went with safety only and did not have data showing efficacy, which is usually the European model,” explained STS President and session co-moderator Joseph E. Bavaria, MD. “This is a different strategy by the FDA. That is why this session was designed.”

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Joseph E. Bavaria, MD will lead a session on treatment of thoracic aortic disease.

Outcomes from TEVAR on patients with type A and other type B dissections will be collected to determine when it is the best treatment option.

“The FDA probably did the right thing. It is reasonable to have the community of cardiothoracic surgeons see these patients and perform these procedures to develop the evidence one way or the other,” said Dr. Bavaria, who is with the University of Pennsylvania School of Medicine in Philadelphia.

The EACTS @ STS session will explore this hot topic via invited lectures and presentation of research results from Europe, Asia, and the United States.

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