FDA Expands TAVR Use; Medicare Broadens Coverage for Edwards Valves
What happened
The FDA expanded the use of Sapien 3 valves for patients with asymptomatic severe aortic stenosis. Separately, the Centers for Medicare & Medicaid Services finalized a decision to expand TAVR coverage to asymptomatic patients, removing prior requirements that limited coverage to clinical studies or data registries.
From ocbj.com
Why it matters
The Medicare decision provides a broader market base for Edwards Lifesciences' transcatheter heart valves. This expansion builds on the FDA's prior approval of the Sapien 3 valves for asymptomatic patients.
The FDA approval enabled the TAVR procedure, with Medicare conditioning payment on STS requirements.
From ocbj.com
Who's involved
- FDARegulatory body that approved expanded use of Sapien 3 valves
- Edwards LifesciencesManufacturer whose transcatheter heart valves benefit from expanded coverage
- MedicareUS federal health insurance that expanded coverage for TAVR procedures
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- Edwards LifesciencesSpeculative
Edwards Lifesciences might see increased revenue due to the broader market base provided by the CMS coverage expansion.
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The entities involved
- FDA
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Edwards Lifesciences
American medical technology company
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Medicare
US federal health insurance