- In May 2025, Shockwave Medical, a Johnson & Johnson MedTech company, presented late-breaking clinical results from the EMPOWER CAD trial at EuroPCR 2025. This trial evaluated the safety and effectiveness of intravascular lithotripsy (IVL) in treating calcified coronary artery disease in women. Results showed a high procedural success rate of 86.9%, low complication rates, and significant quality-of-life improvements at 30 days. This study underscores the expanding use of IVL in diverse patient populations and reinforces Shockwave’s leadership in the IVL market
- In April 2025, Shockwave Medical initiated the FORWARD CAD pivotal IDE study to evaluate its novel Javelin Coronary IVL Catheter, a forward-delivering IVL platform designed for patients with heavily calcified coronary lesions. This innovative catheter aims to simplify lesion crossing and expand treatment to more complex anatomies. The study launch marks a significant milestone in next-generation IVL device development and reflects continued R&D investment in coronary plaque modification technologies
- In March 2025, Elixir Medical received CE mark approval in Europe for its LithiX Hertz Intravascular Lithotripsy System, marking the company’s entry into the European IVL market. The device uses ultra-short electrical pulses to fracture vascular calcium and is positioned as a competitor to Shockwave’s legacy platform. This regulatory milestone supports Elixir's geographic expansion and highlights the growing competitive landscape of the IVL segment
- In April 2025, the U.S. FDA granted 510(k) clearance to Bolt Medical’s Intravascular Lithotripsy platform, enabling Boston Scientific to proceed with commercialization following its acquisition of Bolt. This new entry enhances treatment options for interventional cardiologists and reflects a broader trend toward diversification in the U.S. IVL device space
