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First patient enrolled in FORWARD CAD pivotal study of novel forward intravascular lithotripsy platform - Shockwave Medical/Johnson & Johnson MedTech

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Published:10th Apr 2025
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Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced it has initiated its pivotal FORWARD CAD investigational device exemption (IDE) study. Investigators in the study will assess the safety and effectiveness of the Shockwave Javelin Coronary IVL Catheter for the treatment of calcified, difficult-to-cross stenotic de novo coronary artery lesions prior to stenting. The first patient was treated recently by operators Evan Shlofmitz, D.O., FACC, Director of Intravascular Imaging and Ziad Ali, M.D., D.Phil., Director of the DeMatteis Cardiovascular Institute and Investigational Interventional Cardiology at St. Francis Hospital & The Heart Center in Roslyn, New York.

Coronary artery disease (CAD) is the most common type of heart disease and affects approximately 1 in 20 adults over the age of 20 in the U.S. In CAD, progressive buildup of cholesterol-rich deposits gradually narrows the coronary arteries, reducing blood flow to the heart muscle and leading to chest pain (angina) and heart attacks. Over time, these narrowed vessels may harden and block due to accumulation of calcium, making them more difficult to treat by conventional techniques.

“There is an opportunity to improve the treatment of cardiovascular patients with tight, calcific lesions in narrowed coronary vessels that are challenging to cross with balloon-based approaches as currently we have to rely on atherectomy technologies,” said Dr. Shlofmitz. “We are delighted to enroll the first patient in the FORWARD CAD clinical trial to determine whether Shockwave’s novel forward IVL platform can help reduce the recognized risks of atherectomy in this patient population,” followed Dr. Ali.

A prospective, multicenter, single-arm study across approximately 35 sites in the U.S. and U.K., the FORWARD CAD study aims to enroll up to 158 patients with moderate-to-severely calcified, stenotic de novo coronary artery lesions presenting with stable angina or following stabilization after acute coronary syndrome (ACS) and suitable for non-emergent percutaneous coronary intervention (PCI). The co-global principal investigators of the study are Robert Yeh, M.D., MBA, Beth Israel Deaconess Medical Center and James Spratt, M.D., FRCP, St. George’s University NHS Trust and the U.S. principal investigator is Robert Riley, M.D., FACC, Overlake Medical Center & Clinics.

The forward IVL platform is designed with a single distal emitter that creates ultrasonic shock waves, with a spherical energy field that extends beyond the tip of the catheter. This novel design delivers lithotripsy closer to highly stenosed calcium lesions than balloon-based platforms.

Nick West, M.D., Chief Medical Officer, Shockwave Medical emphasized the potential of the Javelin Coronary IVL Catheter, stating, “Our commitment to realizing the full potential of IVL to optimize cardiovascular care is unwavering, and we believe Javelin has the promise to transform how interventional cardiologists treat patients with tight, challenging-to-cross, calcified coronary lesions. We look forward to learning more about how our enhanced IVL capabilities could lay the foundation for a new era of treatment that improves outcomes for these complex patients.”

Condition: Coronary Artery Disease/Calcified Lesions
Type: drug
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