Shockwave Receives FDA Breakthrough Device Designation for the Coronary IVL System
ShockWave Medical, Inc. (SWAV)
Last shockwave medical, inc. earnings: 2/13 04:03 pm
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Source: GlobeNewswire
SANTA CLARA, Calif., Sept. 03, 2019 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc., a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, today announced that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter, which is currently the subject of an Investigational Device Exemption (IDE) study called DISRUPT CAD III. The Shockwave C2 IVL Catheter is a proprietary tool designed to fracture problematic calcium using sonic pressure waves in order to facilitate stent delivery, deployment and optimal expansion, thereby improving blood flow to the heart muscle. The FDA Breakthrough Device Program is intended to help patients and health care providers receive more timely access to medical devices that have the potential to provide more effective treatment or diagnosis for life-threaten
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