Shockwave Medical, a subsidiary of Johnson & Johnson MedTech, has commenced the FORWARD CAD study to evaluate the Shockwave Javelin Coronary IVL Catheter, an investigational intravascular lithotripsy platform.
This investigational device exemption (IDE) trial will examine the efficacy and safety of the catheter in treating calcified coronary artery lesions that are difficult to cross.
The study is set to involve around 158 patients across approximately 35 locations in the US and the UK. It will focus on individuals with moderate-to-severely calcified, stenotic de novo coronary artery lesions, either presenting stable angina or stabilised post-acute coronary syndrome (ACS).
These patients should also be suitable for non-emergent percutaneous coronary intervention (PCI).
The first patient was recently treated at St. Francis Hospital & The Heart Center in Roslyn, New York by Dr Evan Shlofmitz.
Shlofmitz said: “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.”
Coronary artery disease (CAD) is prevalent among adults over 20 in the US, with cholesterol deposits progressively narrowing arteries, leading to reduced blood flow to the heart and an increased risk of angina and heart attacks. Over time, hardening due to calcium deposits can further complicate conventional treatments.
Shockwave’s forward IVL platform uses a single distal emitter that produces ultrasonic shock waves within a spherical energy field beyond the catheter tip. This design aims to bring lithotripsy closer to highly calcified lesions compared to traditional balloon-based platforms.
Acquired by Johnson & Johnson in 2024 for approximately $13.1bn, Shockwave Medical aims to effectively address challenging calcified plaque in cardiovascular treatment using sonic pressure waves.
Shockwave Medical chief medical officer Nick West said: “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.”
