Shockwave Medical announces new studies evaluating carotid IVL platform
Carotid artery stenting has see a big expansion in recent years after Medicare finalized reimbursements in 2023. However, carotid artery calcification remains a significant limitation to effective lesion preparation and stent deployment. There is now a hope that intravascular lithotripsy (IVL) therapy may help clinicians address that limitation.
Shockwave Medical, a Johnson & Johnson MedTech company, has launched the SKYWARD U.S. investigational device exemption (IDE) clinical program to evaluate the potential of the Shockwave SkyRunner Carotid Intravascular Lithotripsy (IVL) System to break up carotid artery calcium prior to stenting. Johnson & Johnson MedTech said the first patient was treated by vascular surgeon Nicolas Mouawad, MD, MPH, MBA, RPVI, 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,” Mouawad said in a statement. “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.”
The company said the investigational IVL system offers rapid‑exchange capabilities, carotid‑specific sizing and shaft lengths suitable for both transcarotid and transfemoral access.
The SKYWARD IDE includes two prospective, multi-center, single‑arm studies looking at safety and effectiveness when using transcarotid and transfemoral access. Patients are eligible if they have symptomatic or asymptomatic carotid artery disease and face a high risk of complications from carotid endarterectomy (CEA). The studies will evaluate the Shockwave SkyRunner platform when used prior to stenting with commercially available transcarotid or transfemoral stent systems.
The study program will enroll up to 320 patients split between the two access routes at up to 50 U.S. sites. There will be an additional 25 roll-in patients in each study for long-term follow-up through five years.
The national principal investigators for the two studies are:
· William Gray, MD, system chief, division of cardiovascular disease, Main Line Health.
· Nicolas Mouawad, MD, chair and chief of vascular and endovascular surgery, McLaren Bay Region Hospital.
· Peter Schneider, MD, vascular surgeon and professor of surgery, division of vascular and endovascular surgery, University of California, San Francisco.
· Peter Soukas, MD, director of vascular medicine and the interventional vascular laboratories, Miriam and Rhode Island Hospitals.
Shockwave's IVL technologies have already been successful, seeing rapid adoption for the treatment of calcified lesions in both peripheral and coronary vessels. As carotid artery disease causes up to 30% of all strokes, the hope is that IVL can be equally effective in this new area as well.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]