Johnson & Johnson announced the initiation of its SKYWARD investigational device exemption (IDE) clinical program evaluating the novel Shockwave SkyRunner Carotid Intravascular Lithotripsy (IVL) Systemi for the treatment of calcified carotid arteries prior to stenting. The first patient was treated by Nicolas Mouawad, M.D., Surgery Department Chair and Chief of Vascular and Endovascular Surgery at McLaren Bay Region Hospital in Bay City, Michigan.
The SKYWARD program consists of two prospective, multi-center, 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 program will evaluate the Shockwave SkyRunner platform when used prior to stenting with commercially available transcarotid or transfemoral stent systems.
The study program is expected to enroll up to 320 subjects (160 for transcarotid and 160 for transfemoral) across as many as 50 U.S. sites with an additional 25 roll-in patients in each study and includes long-term follow-up through five years. The national principal investigators for the two studies are:
- William Gray, M.D., System Chief, Division of Cardiovascular Disease, Main Line Health
- Nicolas Mouawad, M.D., Surgery Department, Chair and Chief of Vascular and Endovascular Surgery at McLaren Bay Region Hospital
- Peter Schneider, M.D., Vascular Surgeon and Professor of Surgery, Division of Vascular & Endovascular Surgery, University of California, San Francisco
- Peter Soukas, M.D., Director of Vascular Medicine and the Interventional Vascular Laboratories at The Miriam and Rhode Island Hospitals
The investigational Shockwave SkyRunner Carotid IVL system is a distinct, purpose‑built carotid platform designed to be optimized 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, bolstering J&J’s market-leading Shockwave IVL portfolio.
