SHERIDAN, WYOMING – May 5, 2025 – Shockwave Medical, Inc., a Johnson & Johnson MedTech company and global leader in circulatory restoration, has officially initiated its FORWARD CAD Investigational Device Exemption (IDE) study. This pivotal research effort will evaluate the safety and efficacy of the Shockwave Javelin Coronary IVL Catheter for the treatment of difficult-to-cross, heavily calcified coronary artery lesions—an area with high unmet clinical need and procedural risk.
The first patient in the study was successfully treated by Dr. Evan Shlofmitz and Dr. Ziad Ali at St. Francis Hospital & The Heart Center in Roslyn, New York. This milestone underscores the growing clinical interest in Shockwave’s forward IVL (intravascular lithotripsy) platform as a potential alternative to atherectomy, especially in complex percutaneous coronary interventions (PCI).
Advancing Treatment for Challenging Coronary Artery Disease
Coronary artery disease (CAD) remains a leading cause of death globally and affects roughly 5% of U.S. adults over 20. As lesions become more calcified and resistant to traditional interventions, new methods are urgently needed.
“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. Dr. Ali added, “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.”
Strategic Study Design to Inform Future Care
The FORWARD CAD study is a prospective, single-arm, multicenter trial enrolling up to 158 patients across approximately 35 sites in the U.S. and U.K. These patients will present with moderate-to-severe calcified, stenotic de novo coronary lesions and stable angina or post-acute coronary syndrome stabilization.
Key study highlights include:
- Multinational trial coverage across high-volume cardiovascular centers.
- Focused on non-emergent PCI candidates with highly complex lesion profiles.
- Co-led by distinguished principal investigators including Dr. Robert Yeh (Beth Israel Deaconess Medical Center), Dr. James Spratt (St. George's University NHS Trust), and Dr. Robert Riley (Overlake Medical Center & Clinics).
Next-Generation IVL Technology Designed for Precision
Unlike traditional balloon-based IVL systems, the Javelin Coronary IVL Catheter features a single distal emitter that produces ultrasonic shock waves through a spherical energy field. This allows more precise lithotripsy closer to the calcium-laden stenosis, enhancing deliverability and minimizing trauma.
“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,” said Dr. Nick West, Chief Medical Officer at Shockwave Medical. “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.”
A Broader MedTech Vision Backed by Johnson & Johnson
As part of Johnson & Johnson MedTech, Shockwave Medical is strategically positioned to scale its innovations globally. The IVL platform, along with complementary solutions in refractory angina (such as the CE Marked Reducer technology), reinforces the company’s mission to tackle cardiovascular diseases through minimally invasive, outcomes-driven care.
Johnson & Johnson’s broader cardiovascular portfolio further strengthens this direction, with technologies supporting heart rhythm disorders, stroke, heart failure, and neurovascular care. This initiative reflects the organization's integrated vision of enabling smarter, more precise, and more personal health solutions worldwide.
To explore the full potential of the Javelin Coronary IVL Catheter and track progress of the FORWARD CAD study, visit www.shockwavemedical.com.