Johnson & Johnson (J&J) announced today the initiation of its SKYWARD investigational device exemption (IDE) clinical programme evaluating the novel Shockwave SkyRunner carotid intravascular lithotripsy (IVL) system for the treatment of calcified carotid arteries prior to stenting. The first patient was treated by Nicolas Mouawad (McLaren Bay Region Hospital, Bay City, USA).
“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 programme is a major step in evaluating how this technology could advance meaningful treatment options for these challenging patients.”
The SKYWARD programme consists of two prospective, multicentre, single‑arm IDE studies—transcarotid and transfemoral—designed to assess the safety and effectiveness of the Shockwave SkyRunner carotid IVL system in patients with symptomatic or asymptomatic carotid artery disease who are at high risk for complications from carotid endarterectomy (CEA). The study programme will evaluate the Shockwave SkyRunner platform when used prior to stenting with commercially available transcarotid or transfemoral stent systems.
The study programme is expected to enrol up to 320 subjects (160 for transcarotid and 160 for transfemoral) across as many as 50 US sites with an additional 25 roll-in patients in each study and includes long-term follow-up through five years. Alongside Mouawad, the national principal investigators for the two studies are:
- William Gray (Main Line Health, Wynnewood, USA)
- Peter Schneider (University of California, San Francisco, USA)
- Peter Soukas (The Miriam and Rhode Island Hospitals, Providence, USA)
J&J notes that the investigational Shockwave SkyRunner carotid IVL system is a distinct, purpose‑built carotid platform designed to be optimised for the anatomy of the carotid artery. It is designed to feature rapid‑exchange capability and carotid‑specific sizing and shaft lengths suitable for both transcarotid and transfemoral approaches.
