TCT: Shockwave Medical Initiates All-Female Coronary IVL Study

EMPOWER CAD is the First Prospective, Female-Only Study of Coronary Interventions;

Study Seeks to Confirm Benefits of Shockwave’s Coronary IVL in Females Who Historically Have Suffered Less Favorable Clinical Outcomes than Male Patients with Traditional Therapies

SANTA CLARA, Calif., Sept. 19, 2022 - Shockwave Medical, Inc., a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, has initiated the first-ever prospective coronary intervention study consisting of all female patients – EMPOWER CAD – to determine whether the positive results from earlier coronary IVL studies with the Shockwave C² Coronary IVL Catheter, which showed similar safety outcomes across both sexes, can be replicated in an expanded, ‘real-world’ population of female patients with severely calcified coronary lesions. This prospective, multicenter registry will enroll up to 400 female patients with symptomatic ischemic heart disease in up to 50 investigational centers in the United States and Europe and will include a 3-year follow-up.

EMPOWER CAD co-principal investigators Margaret McEntegart, MD, PhD, Director of Complex Percutaneous Coronary Intervention Program at Columbia University Medical Center/New York-Presbyterian Hospital and Alexandra Lansky, MD, FACC, FAHA, FSCAI, FESC, Professor of Medicine, Section of Cardiovascular Medicine and Director, Heart and Vascular Clinical Research Program at Yale University School of Medicine, along with the study’s European lead, Nieves Gonzalo, Consultant Interventional Cardiologist at Hospital Clinico San Carlos in Madrid, Spain, announced the study at the Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation in Boston, Mass.

“When it comes to coronary artery disease (CAD), females are often under-investigated, under-treated and have less favorable outcomes than males due to a variety of different factors,” said Dr. McEntegart. “Previous reports with atherectomy have shown that females with calcified CAD are more susceptible to adverse procedural outcomes compared to males. Despite often being more challenging to treat, female patients are under-represented in published data, and there have been no dedicated prospective studies performed on this population. EMPOWER CAD will be an extremely valuable study to better inform interventional cardiologists on the optimal treatment strategy for these complex patients.”

“Early retrospective analyses have suggested that coronary IVL can potentially bridge the disparity in clinical outcomes between sexes, however the studies only included a limited number of females with strict inclusion criteria,” said Dr. Lansky. “Information that will be gathered in EMPOWER CAD will be immensely valuable, as it will provide more robust data with longer-term outcomes in a larger, all-comers patient cohort to determine whether coronary IVL should be considered the front-line calcium modification approach in female patients.”

“There is much work that needs to be done to close the female inequality gap in the treatment of complex calcified coronary lesions, and this study represents Shockwave’s commitment to this effort,” said Keith D. Dawkins, MD, Chief Medical Officer of Shockwave Medical. “We hope to enhance the clinical evidence with this new study while also taking the opportunity to work with some of the leading female interventionalists in the community, which will empower future generations of clinical trial investigators.”

About Shockwave Medical, Inc.
Shockwave is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. Shockwave aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes. To view an animation of the IVL procedure and for more information, visit www.shockwavemedical.com.