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BioWorld - Tuesday, May 19, 2026
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Home » Shockwave Medical gets FDA nod for intravascular lithotripsy for heart disease
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Shockwave Medical gets FDA nod for intravascular lithotripsy for heart disease

Feb. 16, 2021
By Meg Bryant
Shockwave Medical Inc. said Tuesday that its intravascular lithotripsy (IVL) therapy has won U.S. FDA approval for the treatment of severe coronary artery disease (CAD). The technology, which was granted breakthrough device designation in 2019, is a novel application of lithotripsy, which has long been used to safely shatter kidney stones.
Medical technology Regulatory Cardiovascular FDA PMA

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