Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study of the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Coronary IVL Catheter (FORWARD CAD IDE Study)

A catheter delivers shockwaves to crack open rock-hard calcium deposits inside heart arteries before a stent is placed. This matters because heavily calcified coronary arteries resist standard balloon expansion, leaving stents poorly positioned and prone to failure. Current treatments—high-pressure balloons or rotating burrs—can damage vessel walls or miss deep calcium. The Shockwave Intravascular Lithotripsy (IVL) system uses sonic pressure waves from a miniaturised lithotripter inside the catheter to fracture calcium without harming soft tissue, a technique borrowed from kidney stone treatment. If this single-arm, multicentre Investigational Device Exemption study shows the Javelin catheter is safe and effective, it could give interventional cardiologists a reliable tool for the growing population of older patients with complex calcified disease. Success would mean fewer incomplete stent expansions, reduced repeat procedures, and better long-term outcomes for coronary artery disease—a condition that quietly disables millions and drives emergency admissions across the NHS. The study directly tests a device already in clinical use, so positive results could shift practice within months, not years.