SKYWARD Pivotal Studies of Shockwave SkyRunner Carotid IVL Platform Begin Enrollment

June 25, 2026—Johnson & Johnson announced the initiation of its SKYWARD investigational device exemption (IDE) clinical program evaluating the company’s Shockwave SkyRunner carotid intravascular lithotripsy (IVL) system for the treatment of calcified carotid arteries when used before stenting with a commercially available transcarotid or transfemoral stent system.

According to Johnson & Johnson, the SKYWARD program consists of two prospective, multicenter, single-arm IDE studies: a transcarotid study and a transfemoral study. The studies are designed to assess the safety and effectiveness of the SkyRunner system in patients with symptomatic or asymptomatic carotid artery disease who are at high risk for complications from carotid endarterectomy. SkyRunner is an investigational device only, noted the press release.

The company advised that the study program is expected to enroll up to 320 patients (160 for transcarotid, 160 for transfemoral) across as many as 50 sites in the United States with an additional 25 roll-in patients in each study. Long-term follow-up will be conducted through 5 years.

The National Principal Investigators for the two studies are William Gray, MD; Nicolas Mouawad, MD; Peter Schneider, MD; and Peter Soukas, MD.

Dr. Mouawad treated the first patient in the SKYWARD clinical study program. Dr. Mouawad is Surgery Department Chair and Chief of Vascular and Endovascular Surgery at McLaren Bay Region Hospital in Bay City, Michigan.

“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,” commented Dr. Mouawad in the company’s press release. “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.”