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 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), 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 b 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.
Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others: the impact of the COVID-19 pandemic on our operations, financial results, and liquidity and capital resources, including the impact on our sales, expenses, supply chain, manufacturing, research and development activities, clinical trials, and employees; our ability to develop, manufacture, obtain and maintain regulatory approvals for, market and sell, our products; our expected future growth, including the size and growth potential of the markets for our products; our ability to obtain coverage and reimbursement for procedures performed using our products; our ability to scale our organizational culture; the impact of the development, regulatory approval, efficacy and commercialization of competing products; the loss of key scientific or management personnel; our ability to develop and maintain our corporate infrastructure, including our internal controls; our financial performance and capital requirements; and our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others. These factors, as well as others, are discussed in our filings with the Securities and Exchange Commission (SEC), including in Part I, Item IA - Risk Factors in our most recent Annual Report on Form 10-K filed with the SEC, and in our other periodic and other reports filed with the SEC. Except to the extent required by law, we do not undertake to update any of these forward-looking statements after the date hereof to conform these statements to actual results or revised expectations