Breakthrough heart study: Shockwave’s IVL therapy delivers game-changing results for women with coronary calcium buildup

In a significant advancement for cardiovascular care, Johnson & Johnson MedTech and its subsidiary Shockwave Medical, Inc. presented promising 30-day outcomes from the EMPOWER CAD study at EuroPCR 2025 in Paris. This study is the first prospective, real-world clinical investigation of coronary intravascular lithotripsy (IVL) in female patients with complex, calcified coronary artery disease (CAD). Conducted across 45 sites in five countries, the trial offers robust real-world evidence supporting an IVL-first strategy in a population historically underrepresented in clinical research.

Women with coronary artery calcification face unique procedural risks during percutaneous coronary intervention (PCI). Prior studies have consistently shown that female patients experience worse outcomes than male counterparts, particularly when traditional plaque modification tools like rotational or orbital atherectomy are used. EMPOWER CAD addresses this longstanding gap by evaluating a gentler and targeted approach—IVL—that uses sonic pressure waves to disrupt calcium deposits without damaging surrounding tissue.

The EMPOWER CAD study has emerged as a milestone for interventional cardiology. It is the first prospective, post-market investigation exclusively focused on women, specifically encouraging a Shockwave IVL-first strategy. Unlike previous studies with restrictive exclusion criteria, EMPOWER CAD welcomed a broad real-world population, tracking outcomes for three years post-treatment. This inclusive design enhances its credibility and applicability for daily clinical practice.

How effective was Shockwave IVL in real-world female patients with severe calcification?

The primary endpoint data presented at EuroPCR 2025 reveal a compelling clinical profile for IVL in female patients. At 30 days, procedural success—defined as stent delivery with no more than 30% residual stenosis and without in-hospital target lesion failure (TLF)—was achieved in 86.9% of patients. This result is particularly notable given the complex nature of the lesions treated, which often pose significant challenges even in male patients.

The safety profile also held strong. The 30-day primary safety endpoint, measuring TLF as a combination of cardiac death, myocardial infarction (MI) attributed to the target vessel, or ischemia-driven target lesion revascularization (ID-TLR), was recorded at 12.1%. A key nuance here is that 10.6% of TLFs were due to periprocedural MIs, many of which occurred without clinical symptoms, reflecting a technical classification rather than symptomatic deterioration. Cardiac deaths and ID-TLRs each contributed just 1.3% to this figure. The incidence of serious angiographic complications was negligible, with only one case reported among the 399 enrolled patients.

Furthermore, health-related quality of life (HRQoL) scores improved significantly within 30 days of the procedure, indicating both subjective and objective benefits of IVL therapy in this population. These early gains offer encouraging signals that IVL may change the trajectory of cardiovascular outcomes for female patients long considered at elevated procedural risk.

What makes the EMPOWER CAD study different from prior research?

Shockwave Medical’s EMPOWER CAD study stands apart due to its focused population, real-world design, and long-term commitment to follow-up. Historically, women have been underdiagnosed and underrepresented in interventional cardiology trials. This study is the first of its kind to place women at the center of a multi-center clinical investigation targeting calcified CAD—a condition that disproportionately affects outcomes in female patients due to differences in vascular biology and plaque morphology.

The study was co-led by a distinguished team of female cardiologists: Dr. Margaret McEntegart of Columbia University Medical Center and Dr. Alexandra Lansky of Yale University School of Medicine, with Dr. Nieves Gonzalo leading the European component from Hospital Clinico San Carlos. Their collective leadership not only reflects the study’s commitment to gender equity but also helps ensure insights from experienced interventionists influence protocol design and interpretation.

In addition to promoting an IVL-first strategy, EMPOWER CAD is tracking participants over a three-year period. This extended observation window is expected to yield valuable insights into the long-term safety, restenosis rates, and sustained benefits of IVL therapy. By combining short-term procedural success with long-term outcome tracking, the study is uniquely positioned to influence guideline recommendations for female patients with calcified lesions.

How does IVL differ from conventional plaque modification tools?

Intravascular lithotripsy (IVL) is a minimally invasive technique that delivers sonic pressure waves to fracture both superficial and deep calcium in the arterial wall without damaging soft tissue. Unlike high-speed rotational or orbital atherectomy devices, which physically grind calcium, IVL minimizes the risk of vessel perforation and dissection—a key concern in women with smaller vessels and more diffuse disease.

Shockwave Medical’s IVL technology has already been widely adopted for treating heavily calcified lesions in both peripheral and coronary arteries. However, until EMPOWER CAD, robust real-world data specific to women had been sparse. The current study reinforces the notion that IVL provides a safer, more effective alternative to conventional modalities, especially for anatomically and physiologically distinct female patients.

In many catheterization labs, IVL is increasingly viewed as the first-line strategy for modifying coronary calcium, thanks to its simplified learning curve and improved safety profile. EMPOWER CAD now provides evidence to extend this preferential use to female patients, who have historically experienced suboptimal outcomes with more aggressive mechanical techniques.

What are the broader implications for cardiovascular medicine and patient equity?

The results from EMPOWER CAD go beyond validating a single device—they challenge the prevailing norms of patient inclusion and procedural strategy in interventional cardiology. By proving that an IVL-first approach yields strong outcomes in women, Shockwave Medical and Johnson & Johnson MedTech are pushing the field toward a more individualized and equitable treatment paradigm.

Nick West, Chief Medical Officer at Shockwave Medical, emphasized the transformative potential of these findings, noting the importance of accelerating awareness and adoption of IVL in underrepresented groups. With cardiovascular disease continuing to be the leading cause of death in women globally, incorporating gender-specific strategies in both clinical research and practice is no longer optional—it is essential.

This study’s implications may also resonate with regulators, payers, and professional societies as they consider updates to guidelines and reimbursement frameworks. Real-world, post-market evidence like that from EMPOWER CAD plays a critical role in translating innovation into standard of care, particularly when addressing historically underserved populations.

What’s next for Shockwave Medical and the future of IVL in women’s cardiovascular health?

While the 30-day findings from EMPOWER CAD offer substantial validation, the study is far from over. Longitudinal data from the ongoing three-year follow-up phase will provide deeper insights into durability, restenosis, and comparative outcomes with other modalities. These extended results will be crucial in determining how widely the IVL-first strategy should be adopted in female patients and may inform future guideline updates from cardiology societies.

Shockwave Medical, a key business within Johnson & Johnson MedTech, continues to drive innovation in circulatory restoration technologies. Beyond coronary IVL, the company is also advancing its Reducer system for refractory angina and expanding indications for IVL across various vascular beds. Its technology portfolio is increasingly being positioned at the intersection of safety, efficacy, and equity in cardiovascular treatment.

The EMPOWER CAD study underscores the importance of designing clinical trials that reflect real-world patient diversity. As the global healthcare system evolves toward more personalized, data-driven care, initiatives like this will shape the future of cardiology—not just for women, but for all patients with complex coronary disease.