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 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.
Forward-Looking StatementsThis press release
contains statements relating to our expectations, projections,
beliefs, and prospects, which are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995. In some cases, you can identify these statements by
forward-looking words such as “may,” “might,” “will,” “should,”
“expects,” “plans,” “anticipates,” “believes,” “estimates,”
“predicts,” “potential” or “continue,” and similar expressions, and
the negative of these terms. You are cautioned not to place undue
reliance on these forward-looking statements. Forward-looking
statements are only predictions based on our current expectations,
estimates, and assumptions, valid only as of the date they are
made, and subject to risks and uncertainties, some of which we are
not currently aware.
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
Media Contact:Scott
Shadiow+1.317.432.9210sshadiow@shockwavemedical.com
Investor Contact:Debbie Kasterdkaster@shockwavemedical.com
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