Abbott (ABT) announced that the U.S. Food and Drug Administration, FDA, has approved an investigational device exemption, IDE, for its Coronary Intravascular Lithotripsy, IVL, System to evaluate the treatment of severe calcification in coronary arteries prior to stenting. The TECTONIC Coronary Artery Disease, CAD, Intravascular Lithotripsy, IVL, clinical trial will enroll up to 335 people in 47 sites in the U.S.
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