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Balloon-expandable valve receives FDA approval for aortic, mitral valve-in-valve procedures
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Edwards Lifesciences Corp. announced the FDA approved its transcatheter heart valve for use in aortic and mitral valve-in-valve procedures.
According to a press release, the balloon-expandable valve (Sapien 3) is the first transcatheter heart valve approved in the U.S. for treatment in both sets of patients who are at high risk for another open-heart procedure to replace a failed bioprosthetic valve.
"This approval brings a safe and effective transcatheter therapy to patients who would do very poorly with repeat open-heart surgery," John D. Carroll, MD, professor of cardiology at the University of Colorado School of Medicine and director of interventional cardiology at the University of Colorado Hospital, Denver, said in the release.
The approval was supported by real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry, which consists of information and outcomes on patients undergoing TAVR and repair procedures across the U.S., according to the release.
"I am pleased to see that the FDA recognizes the value of the high-quality evidence generated by the STS/ACC TVT Registry and its ability to play an important role in assessing real-world clinical results in specialty indications, such as valve-in-valve, and for particular patient groups, such as those needing replacement of a bioprosthetic mitral valve,” Carroll said in the release.
Disclosure: Carroll reports receiving research funding from Direct Flow Medical, Edwards Lifesciences and Medtronic, and serving on a data safety and monitoring board and a clinical events committee for Tendyne.
Perspective
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Danny Dvir, MD
These new indications are important. Especially for the mitral position. Patients with failed aortic bioprostheses already have an indication to use Sapien XT (Edwards Lifesciences) and CoreValve/Evolut R (Medtronic) platforms. However, in the mitral position in the U.S., we basically had no indication for a less invasive transcatheter treatment for patients with a failed valve after surgery.
This is especially important since redo mitral surgery is commonly a very high-risk procedure and many of these patients have cardiomyopathy and other comorbidities.
A very large set of data gathered in the VIVID registry, mostly from European sites, show that mitral valve-in-valve is a very effective procedure, and I believe that this indication is truly lifesaving for many patients that did not have good options before.
In the future, when large data will accumulate, we will need to learn how to utilize Sapien 3 optimally in failed surgical valves to continue to improve our clinical outcomes. In addition, treatment of patients with failed mitral rings and those with severe mitral annular calcification should be continued to be studied, as the clinical outcomes in these scenarios are unfortunately inferior.
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