chas kicked off its SKYWARD investigational device exemption (IDE) clinical program, evaluating the new Shockwave SkyRunner Carotid Intravascular Lithotripsy (IVL) System for treating heavily calcified carotid arteries prior to stent placement.

 

The milestone comes with the treatment of the first patient, performed by Nicolas Mouawad, Chair of the Surgery Department and Chief of Vascular and Endovascular Surgery at McLaren Bay Region Hospital in Bay City, Michigan.

 

Carotid artery disease accounts for up to 30% of all strokes and develops when plaque builds up in the arteries supplying blood to the brain. Over time, this plaque can harden, narrowing or blocking blood flow.

 

In patients with severe calcification, both open surgical and endovascular procedures become more technically difficult and carry higher procedural risk. Although carotid artery stenting has broadened treatment options for high-risk surgical patients, heavy calcification continues to limit effective vessel preparation and stent deployment.

 

"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,” said Mouawad. 

 

“The SkyRunner Carotid IVL System offers a purpose-built and fundamentally different way to prepare the artery for stenting, and enrolling the first patient in the SKYWARD clinical study program is a major step in evaluating how this technology could advance meaningful treatment options for these challenging patients.”