Shockwave completes enrolment in study of coronary intravascular lithotripsy

Shockwave Medical has completed enrolment in its US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study—DISRUPT CAD III—for the use of intravascular lithotripsy (IVL) for the management of heavily calcified coronary arteries. A press release reports that the investigational Shockwave IVL system with the Shockwave C2 Coronary IVL catheter, which has been [...]

2020-04-08T16:04:21+00:00April 8th, 2020|Tags: , , |

FDA Breakthrough Device Designation for coronary lithotripsy system

Shockwave Lithotripsy Shockwave Medical has received Breakthrough Device Designation from FDA for its Shockwave intravascular lithotripsy (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. A press release reports that the Shockwave C2 IVL catheter is [...]

2019-09-06T17:29:11+00:00September 6th, 2019|Tags: , , |
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