Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the
development of Intravascular Lithotripsy (IVL) to treat severely
calcified cardiovascular disease, announced today new data
confirming excellent one-year outcomes with coronary IVL in both
women and men. The one-year results from the Disrupt CAD clinical
program were presented at the 2022 Scientific Sessions of the
Society for Cardiovascular Angiography & Interventions
(SCAI).
Unlike previous reports with atherectomy that have shown worse
angiographic complications in women versus men,i a pooled analysis
of the Disrupt CAD III & IV studies showed that IVL was equally
safe and effective in men (n=342) and women (n=106). Despite the
smaller vessel size in women (2.8mm vs 3.1mm, p=<0.001), the
primary effectiveness endpoint of procedural success for women and
men was similar (90.6 percent vs 93.0 percent, p=0.47). The primary
safety endpoint of 30-day MACE for women and men was also similar
(9.4 percent vs 7.0 percent, p=0.55). Notably, there were also
consistently low rates of post-IVL serious angiographic
complications in women and men (2.2 percent vs 2.6 percent,
p=0.85), which differs from similar analyses in an atherectomy
population.
At one year, women and men had similar rates of MACE (12.7
percent vs 13.3 percent, p=0.83) and target lesion failure (10.4
percent vs 11.2 percent, p=0.85), respectively. The components of
target lesion revascularization (TLF) were low in both women and
men and numerically favored females, including target
vessel-myocardial infarction (8.5 percent vs 9.7 percent), target
lesion revascularization (2.9 percent vs 4.2 percent) and stent
thrombosis (0 percent vs 1.2 percent).
“Given the established safety profile of IVL and the high rates
of acute and long-term adverse events in women undergoing PCI, with
or without atheroablation of calcified lesions, coronary IVL is an
attractive treatment option for optimizing outcomes in our female
patients,” said Alexandra Lansky, MD, FACC, FAHA, FSCAI, FESC,
Professor of Medicine (Cardiology); Director of Yale Cardiovascular
Clinical Research Program, Yale University School of Medicine, New
Haven, Conn. “While this is the first one-year analysis of its kind
for coronary IVL, the sustained benefit in MACE at one year
suggests that IVL should be considered first-line therapy for
plaque modification in women with calcified lesions.”
The presentation follows the recent publication of SCAI’s
“Expert Consensus Statement on Sex-Specific Consideration in
Myocardial Revascularization” in JSCAI, which referenced the role
of IVL in female patients. The SCAI statement concluded, “while
additional evidence is needed, these results taken in the context
of outcomes with atherectomy devices suggest that IVL may emerge as
a first-line therapy for plaque modification of calcified lesions
in women specifically.”
“As someone who is dedicating her career to addressing the needs
of the most complex patients, I find these results very
encouraging,” said Katherine Kunkel, MD, MSEd, FSCAI, an
interventional cardiologist at Piedmont Heart Institute in Atlanta,
Ga., one of the sites that participated in Disrupt CAD III. “Thanks
to an increasing focus on the challenges of female patients, which
often include atypical symptoms, later presentation with smaller
and more tortuous vessels, and possibly an unconscious bias that
may be associated with under-treatment, I am confident that we are
heading in the right direction to improve outcomes in female
patients. Additionally, tools like IVL are helping level the
playing field for safely and effectively treating all types of
patients with calcified disease.”
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
______________________________________i
https://onlinelibrary.wiley.com/doi/10.1002/ccd.28373
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