Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the
development and commercialization of transformational technologies
for the treatment of cardiovascular disease, announced today new
data demonstrating excellent one-year outcomes with coronary
intravascular lithotripsy (IVL) that was consistent in both women
and men. The one-year results from Disrupt CAD III and IV trials
were recently published in the Journal of the Society for
Cardiovascular Angiography & Interventions (JSCAI).
In the patient-level pooled analysis, titled
“Coronary Intravascular Lithotripsy for Treatment of Severely
Calcified Lesions: Long-Term Sex-Specific Outcomes,” use of IVL for
lesion preparation of severely calcified lesions had similar safety
and effectiveness in women and men at a one-year follow-up. This is
in contrast to atheroablative approaches to vessel preparation,
where previous reports show that women are more susceptible to
adverse procedural outcomes compared with men.i
The publication reported that despite smaller
average reference vessel diameters (2.8 mm vs 3.1 mm) in women
(n=106) compared with men (n=342), post-IVL serious angiographic
complications, defined as a composite of severe dissection,
perforation, abrupt closure, slow-flow, or no-reflow, were similar
between women and men (2.2% vs 2.6%, p=0.85). At one-year, major
adverse cardiovascular event (MACE) rates were not different
between women and men (12.3% vs 13.2%, p=0.52) and there was no
difference between women and men in target lesion failure (TLF,
10.4% vs. 11.2% p=0.43). Sex was also not an independent predictor
of MACE at one year (HR, 1.24; p = 0.52) after adjusting for major
clinical and angiographic covariates.
“The high acute procedural success rate associated
with IVL, the infrequent complications and similar one-year
clinical outcomes is overall favorable, suggesting that the use of
IVL in women is very beneficial in this retrospective analysis,”
said Alexandra Lansky, MD, Professor of Medicine (Cardiology),
Director of Yale Cardiovascular Clinical Research Program, Yale
University School of Medicine, New Haven, CT, USE. “Given these
findings, I am even more excited to see the results from the
prospective, 400-patient EMPOWER CAD study that has recently
started to see how we can better inform interventional
cardiologists on the optimal strategy to treat women suffering from
coronary artery disease in a ‘real-world‘ setting.”
EMPOWER CAD is the first prospective, women-only
study of coronary interventions and aims to confirm the benefits of
coronary IVL in this under-represented patient population. The
first patient was enrolled in May 2023 by Richard A. Shlofmitz, MD,
Chairman, Department of Cardiology, St. Francis Hospital in Roslyn,
NY, USA. The co-principal investigators for EMPOWER CAD are
Margaret McEntegart, MD, PhD, Director of Complex Percutaneous
Coronary Intervention Program at Columbia University Medical
Center/New York-Presbyterian Hospital and Alexandra Lansky, MD. The
European lead is Nieves Gonzalo, MD, PhD, Consultant Interventional
Cardiologist at Hospital Clinico San Carlos in Madrid, Spain.
About Shockwave Medical,
Inc.
Shockwave Medical is a leader in the development
and commercialization of innovative products that are transforming
the treatment of cardiovascular disease. Its first-of-its-kind
Intravascular Lithotripsy (IVL) technology has transformed the
treatment of atherosclerotic cardiovascular disease by safely using
sonic pressure waves to disrupt challenging calcified plaque,
resulting in significantly improved patient outcomes. Shockwave has
also recently acquired the Neovasc Reducer, which is under clinical
investigation in the United States and is CE Marked in the Europe.
By redistributing blood flow within the heart, the Reducer is
designed to provide relief to the millions of patients worldwide
suffering from refractory angina. Learn more
at www.shockwavemedical.com and www.neovasc.com.
Forward-Looking Statements
This 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.
Forward-looking statements in this press release include, but are
not limited to, statements regarding potential future results of
pending clinical trials. 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 are discussed in our
filings with the Securities and Exchange Commission (SEC),
including in the sections titled “Risk Factors” in our most recent
Annual Report on Form 10-K and subsequently filed Quarterly Reports
on Form 10-Q, and in our 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
*Dr. Lansky is a paid consultant of Shockwave
Medical. She has not been compensated in connection with this press
release.
ihttps://onlinelibrary.wiley.com/doi/10.1002/ccd.28373; Abstract
Poster Session, Poster B-9: Gender Difference in Procedural
Complications of Atherectomy: Indiana University, Christopher
Janish, M.D, SCAI 2023; Abstract Poster Session, Poster B-26:
Orbital Atherectomy Clinical and Procedural Outcomes: Indiana
University, Jack Tiahnybik, DO, SCAI 2023.
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