Shockwave Receives FDA Breakthrough Device Designation for the Coronary IVL System
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.
- 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.
- Under the program, the FDA will provide Shockwave Medical with priority review and interactive communication during the Shockwave C2 IVL Catheter premarket review phase.
- Receiving Breakthrough Device Designation is an important milestone, validating IVL as a unique solution for complex calcified coronary disease, said Doug Godshall, President and Chief Executive Officer of Shockwave Medical.
- DISRUPT CAD III is a prospective, non-randomized, multicenter global IDE study to demonstrate the safety and effectiveness of the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter in de novo, calcified, stenotic, coronary arteries prior to stenting.