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FDAnews Device Daily Bulletin

Shockwave Gains Breakthrough Designation for Catheter

Sept. 6, 2019

The FDA granted Shockwave Medical a breakthrough device designation for a catheter used with its Shockwave intravascular lithotripsy (IVL) system.

The designation is for the Shockwave IVL system with the C2 Coronary IVL catheter, a tool that uses sonic pressure waves to break up calcium buildup and enable stent delivery and expansion to improve blood flow to the heart muscle.

Coronary artery calcium impairs blood flow and restricts artery dilation, which inhibits stent expansion. The calcium is “perhaps the single most important predictor of restenosis and early stent thrombosis, or coronary artery re-narrowing and blood clots, within the stent after-stent procedures,” the company said.

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