Surgical Robotics Technology
- U.S. IDE study program will evaluate the purpose-built Shockwave™ SkyRunner Carotid IVL System designed to address the challenges of calcification in carotid arteries prior to stenting
- Clinical program is part of Johnson & Johnson’s plan to enhance treatment options for patients with carotid artery disease, which accounts for up to one-third of all strokes
Johnson & Johnson has 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.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,” said Dr. 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 program is a major step in evaluating how this technology could advance meaningful treatment options for these challenging patients.”
About the SKYWARD IDE Program
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
Developing a Purpose-Built Carotid IVL Platform:
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.
“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,” said Nick West, M.D., Chief Medical Officer, Shockwave Medical, MedTech, Johnson & Johnson. “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.”
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to the Shockwave™ SkyRunner Carotid IVL System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at:
www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
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.
Source: Johnson & Johnson
