The SKYWARD FDA investigational device exemption (IDE) study evaluates the novel SkyRunner carotid intravascular lithotripsy (IVL) system for the treatment of calcified carotid arteries prior to stenting.
SkyRunner, a distinct, purpose-built carotid platform, is optimized for the anatomy of the carotid artery. J&J designed it to feature rapid-exchanging capability and carotid-specific sizing. It also has shaft lengths suitable for both transcarotid and transfemoral approaches.
Johnson & Johnson said it builds on its market-leading Shockwave IVL portfolio.
Dr. Nicolas Mouawad of McLaren Bay Region Hospital in Bay City, Michigan, treated the first patient.
Read more about the Johnson & Johnson Shockwave technology in a recent MassDevice interview with chief medical officer Dr. Nick West.
J&J says that both surgical and endovascular treatment options can prove complex for patients with severely calcified lesions. They often come with increased procedural risk as well.
Carotid artery stenting has expanded treatment options for those at high risk for surgery, the company says, but carotid artery calcification remains a significant limitation to effective lesion preparation and stent deployment.
To address this, the company seeks to evaluate the SkyRunner IVL system in the SKYWARD program. SKYWARD features two prospective, multi-center, single-arm IDE studies of transcarotid and transfemoral approaches. It aims to assess the IVL system’s safety and effectiveness in patients with symptomatic or asymptomatic carotid artery disease who are at high risk for complications from carotid endarterectomy (CEA).
Investigators intend to evaluate SkyRunner when used prior to stenting with commercially available transcarotid or transfemoral stents. They expect to enroll up to 320 subjects (split evenly between arms) across up to 50 U.S. sites, plus an additional 25 roll-in patients. The study also includes long-term follow-up through five years.
Commentary from Shockwave officials and investigators
Dr. West said:
“Shockwave IVL has become a trusted standard for modifying vascular calcification in coronary and peripheral interventions, and we believe its potential extends well beyond where it’s used today. SKYWARD reflects what happens when innovation is driven in lockstep with physicians’ needs. We listened to what they told us they needed in the carotid space and responded with a first-of-its-kind, purpose-built platform designed for calcific carotid disease. This clinical program is about generating the evidence physicians have asked for so we can expand treatment options and advance outcomes for patients with challenging calcific carotid disease.”
Dr. Mouawad said:
“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. 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.”
