Johnson & Johnson Begins Enrollment in Pivotal Studies Evaluating its Carotid IVL Platform

Johnson & Johnson today announced the start of its SKYWARD investigational device exemption (IDE) clinical program evaluating the Shockwave SkyRunner Carotid Intravascular Lithotripsy (IVL) Systemⁱ for treating calcified carotid arteries before 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.ⁱⁱ

Carotid artery disease is responsible for up to 30% of all strokes and occurs when plaque accumulates in the arteries that supply blood to the brain.^iii,iv,v Over time, this plaque can accumulate and harden, causing arteries to become narrowed or blocked and reduce blood flow. In patients with severely calcified lesions, both surgical and endovascular treatment options can be technically complex and associated with increased procedural risk.^vi While carotid artery stenting has expanded treatment options for patients at high‑risk for surgery, carotid artery calcification remains a significant limitation to effective lesion preparation and stent deployment.^vii

“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,” Dr. Mouawad said. “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 SKYWARD program consists of two prospective, multicenter, single-arm IDE studies—transcarotid and transfemoral—that will assess the Shockwave SkyRunner Carotid IVL System’s safety and effectiveness in patients with symptomatic or asymptomatic carotid artery disease who are at high risk for carotid endarterectomy (CEA) complications. The program will evaluate the Shockwave SkyRunner platform when used before stenting with commercially available transcarotid or transfemoral stent systems.

The study program will enroll up to 320 subjects (160 for transcarotid, 160 for transfemoral) across as many as 50 U.S. sites, with an additional 25 roll-in patients in each trial and 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 optimized for carotid artery anatomy. It features rapid‑exchange capability and carotid‑specific sizing as well as shaft lengths suitable for both transcarotid and transfemoral approaches.

“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,” Shockwave Medical Chief Medical Officer Nick West, M.D., stated. “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.”

Part of Johnson & Johnson, Shockwave Medical Inc. develops and commercializes products for treating cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has improved atherosclerotic cardiovascular disease treatment by safely using ultrasonic acoustic pressure waves to disrupt challenging calcified plaque, resulting in considerably better patient outcomes. Its Reducer technology, under clinical investigation in the United States and CE Marked in the European Union and the United Kingdom, provides relief to patients suffering from refractory angina by redistributing blood flow within the heart.

Johnson & Johnson’s cardiovascular portfolio provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation to address conditions such as heart failure, coronary artery disease, stroke, and atrial fibrillation. The medtech behemoth consider itself the global leader in heart recovery, circulatory restoration, and heart rhythm disorder treatment, as well as an emerging leader in neurovascular care. Johnson & Johnson’s expertise in Innovative Medicine and MedTech positions the company to innovate across the full spectrum of healthcare solutions to deliver the breakthroughs.

References
ⁱ Shockwave SkyRunner Carotid Intravascular Lithotripsy (IVL) System is an investigational device only.
ⁱⁱ Dr. Mouawad is a paid consultant for Shockwave Medical. He has not been compensated in connection with this press release. 
ⁱⁱⁱ De Weerd M, Greving JP, Hedblad B, Lorenz MW, Mathiesen EB, O’Leary DH, Rosvall M, Sitzer M, Buskens E, Bots ML. Prevalence of asymptomatic carotid artery stenosis in the general population: an individual participate data meta-analysis. Stroke. 2010 Jun;41(6) 1294-7. Doi: 10.1161/STROKEAHA.110.581058. Epub 2010 Apr 29. PMID: 20431077; PMCID: PMC4254855.
^iv Oaja E, Tadi P, Theetha Kariyanna P. Symptomatic Carotid Artery Stenosis. [Updated 2024 Feb 12]. In: StatPearls [internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. Available from: https://www.ncbi.nim.nih.gov/books/NBK442025/
^v Prasad K. Pathophysiology and Medical Treatment of Carotid Artery Stenosis. Int J Angiol. 2015 Sep;24(3):158-72. Doi: 10.1055/s-0035-1554911. Epub 2015 Jun 23. PMID: 26417183; PMCID: PMC4572017.
^vi Singh J, Kuhn AL, Massari F, Einazeir M, Kutcher R, Puri AS. Intravascular lithotripsy for severely calcified carotid artery stenosis – A new frontier in carotid artery stenting? Interv Neuroradiol. 2023 Dec; 29(6): 768:-772. Doi: 10.1177/15910199221097887. Epub 2022 May 3. PMID: 35505603; PMCID: PMC10680962.
^vii Maria Coluccio, Anoushiravan Amini, Evan C. Lipsitz, Saadat Shariff. Intravascular lithotripsy to facilitate transcarotid artery revascularization in patients with heavily calcified carotid arteries, Annals of Vascular Surgery – Brief Reports and Innovations, Volume 4, Issue 2, 2024. 100283, ISSN 2772-6878, https://doi.org/10.1016/j.avsurg.2024.100283.