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Big news from the FDA — and a big step forward in the fight against silent heart disease
May 01, 2025

From 2017 to 2020, 127.9 million U.S. adults (48.6%) were diagnosed with some form of cardiovascular disease (CVD). But research suggests more than half of American adults remain unaware of the severity and prevalence of heart disease — pointing to a significant undiagnosed population.

In particular, valvular heart disease becomes increasingly common with age. While fewer than 1% of adults under 45 have significant valve disease, prevalence rises to ~4–5% by age 60, 8.5% by 65–74, and 13.2% in those over 75. The U.S. population aged 50 and above is large with over one-third of the total population falling in this at-risk category.

Valve conditions like Aortic Stenosis (AS) often progress silently. And when symptoms do appear, 1 in 10 people with severe AS may die within five weeks if left untreated.

Until now, treatment focused on patients already showing symptoms. But with FDA approval for TAVR in asymptomatic severe AS, the clinical focus will now shifts toward earlier intervention — and with it, a growing urgency for scalable, symptom-independent detection. That’s exactly where Sparrow BioAcoustics is focused: detecting structural heart disease before symptoms appear — using only a smartphone and Sparrow’s FDA cleared, breakthrough class of bioacoustics AI that detects structural abnormalities of the heart. If treatment is moving earlier, detection must follow. The missing link is scalable access.

https://www.businesswire.com/news/home/20250501280519/en/Edwards-TAVR-Receives-FDA-Approval-for-Patients-With-Asymptomatic-Severe-Aortic-Stenosis