Dive Brief:
- European medical societies have lowered the recommended age for transcatheter aortic valve replacement to 70 years.
- The change, which was described in updated guidelines Friday, was part of a set of revisions that included a stronger recommendation for the use of TAVR in asymptomatic patients.
- William Blair analysts said in a note to investors that Edwards Lifesciences, Medtronic and Abbott should benefit from the five-year reduction in the recommended age threshold.
Dive Insight:
The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery set the recommended age for TAVR at 75 years when they published their previous guidelines in 2021. After considering the latest evidence, the groups recommended TAVR as the primary treatment modality for patients aged 70 years and older “to reduce the risk of early adverse outcomes and accelerate recovery.”
William Blair analysts said that all TAVR players, namely Edwards, Medtronic and Abbott, should benefit “as the therapy algorithm is further streamlined and additional patients are encouraged to receive TAVR over [surgical aortic valve replacement].”
The analysts cited a 2024 analysis of a transcatheter valve therapy registry as evidence that the revised guidelines “will be most meaningful to opening the low-risk patient funnel.” That inference reflects the registry analysis finding that the average age of low-risk TAVR patients is 75 years.
William Blair analysts named changes to low-risk, asymptomatic TAVR recommendations as the other key update. The recommendations “were streamlined and now include stronger wording stating intervention ‘should be considered’ for asymptomatic patients,” the analysts said. While all companies could benefit from the age reduction, the analysts said the asymptomatic change strengthens Edwards’ position.
“Edwards is the only TAVR system with asymptomatic approval, so this is a tailwind specifically for it,” the analysts said. “Off-label use in the TAVR space is relatively rare, so this can be a nice competitive win for Edwards going forward.”
Dan Lippis, Edwards’ leader for Japan, Greater China and Asia Pacific, commented on the asymptomatic opportunity on the company’s second-quarter earnings call in July. Lippis said the asymptomatic indication is what Edwards is “most optimistic about” in Europe, adding that the team thinks “that’s going to be a real game changer for the longer term.”
Edwards CEO Bernard Zovighian, in a statement Friday, said the new guidelines “are important advancements for structural heart disease patients.” Edwards singled out the new age threshold and changes to the asymptomatic recommendations as the key changes.
The company could also benefit from an update to the recommendations on transcatheter edge-to-edge repair. William Blair analysts said the new guidelines advise TEER therapy “should be considered” for patients with functional mitral regurgitation and patients with severe functional tricuspid regurgitation. Previously, the guidelines said the therapy may be considered or recommended.
“These should be wins for both Abbott and Edwards with their respective TEER devices in Europe,” the analysts said.
