Johnson & Johnson (JNJ) said Thursday that the first patient has been treated in an investigational device exemption clinical program evaluating its Shockwave SkyRunner Carotid Intravascular Lithotripsy system.
The company said the system is intended to treat calcified carotid arteries prior to stenting.
Carotid artery disease accounts for up to 30% of all strokes, and occurs when plaque accumulates in the arteries that supply blood to the brain.
"Calcium in the carotid artery is a major clinical challenge given the risks and complexity it introduces, and today, many patients have limited treatment options, especially those who are too high-risk for carotid endarterectomy," Nicolas Mouawad, chair and chief of vascular and endovascular surgery at McLaren Bay Region Hospital in Bay City, Michigan said in a statement. Mouawad treated the first patient in the study.