SHOCKWAVE COMPLETES ENROLLMENT IN PIVOTAL STUDY FOR CORONARY INTRAVASCULAR LITHOTRIPSY
ShockWave Medical, Inc. (SWAV)
Last shockwave medical, inc. earnings: 2/13 04:03 pm
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Source: GlobeNewswire
SANTA CLARA, Calif., April 06, 2020 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the company has completed enrollment in the pivotal U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study – DISRUPT CAD III – for the use of IVL in heavily calcified coronary arteries. The investigational Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter, which has been granted Breakthrough Device Designation by the FDA, is an innovative therapy designed to fracture problematic calcium using sonic pressure waves in order to facilitate stent delivery, deployment and optimal expansion. The co-principal investigators of the study are Dean Kereiakes, M.D., FACC, FSCAI, Medical Director of The Christ Hospital Heart and Vascular Center and the Christ Hospital Research Institute, Professor of
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