Shockwave Medical, a part of Johnson & Johnson MedTech, said that the EMPOWER CAD study has revealed a significant 86.9% procedural success rate for intravascular lithotripsy (IVL) in treating women with complex calcified coronary lesions.
The findings were presented at the EuroPCR 2025 meeting in Paris, underscoring the effectiveness of an IVL-first strategy for female patients.
This global, multi-centre study, covering 45 sites across the European Union and the US, is the first of its kind to focus on real-world PCI outcomes in women with calcified coronary artery disease. Historically, women with coronary artery calcification have faced higher risks of procedural complications and adverse outcomes with traditional calcium modification tools like rotational or orbital atherectomy.
Led by co-principal investigators Dr Margaret McEntegart from Columbia University Medical Center/NewYork-Presbyterian Hospital and Dr Alexandra Lansky from Yale University School of Medicine, along with European lead Dr Nieves Gonzalo from Madrid, the study enrolled 399 female participants. It aimed to confirm previous analyses demonstrating IVL’s superior safety and effectiveness compared to other treatments.
McEntegart said: “By leveraging a Shockwave IVL-first approach, the EMPOWER CAD 30-day results demonstrated high procedural success, low complication rates and significant improvements in quality of life among real-world female patients.
“While we look forward to following these patients for the next three years, these primary endpoint results confirm that excellent outcomes can be achieved with the use of Shockwave IVL in women with complex, calcified coronary artery disease.”
The study’s primary safety endpoint—target lesion failure within 30 days due to cardiac death, myocardial infarction linked to target vessel, or ischemia-driven revascularisation—was recorded at 12.1%.
Most periprocedural myocardial infarctions were asymptomatic, while rates of cardiac death and ischemia-driven revascularization stood at 1.3%. Only one serious procedural complication was noted among participants.
Additionally, there were notable improvements in health-related quality of life scores among participants 30 days after treatment compared to baseline.
Shockwave Medical chief medical officer Nick West said: “Today marks a critical milestone in the journey to improve outcomes for female patients with calcified lesions.
“What began as an idea a few years ago is now a commendable reality today, thanks to study leadership and site investigators accelerating completion and reporting these important results. We’re looking forward to learning more about the benefits of IVL therapy in this underrepresented patient population, both acutely and at extended follow-up.”
Shockwave Medical was acquired by Johnson & Johnson in 2024 in a deal worth around $13.1bn.
