Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the
development and commercialization of transformational technologies
for the treatment of cardiovascular disease, announced today that
two new publications reported excellent and consistent outcomes
with coronary intravascular lithotripsy (IVL) in both nodular and
eccentric calcium. The publications each reported separate
patient-level pooled optical coherence tomography (OCT)
sub-analyses of the company-sponsored Disrupt CAD clinical studies.
“While the majority of the robust, core-lab adjudicated evidence
supporting coronary IVL to date has studied concentric calcium, we
are beginning to see a shift in evidence reinforcing IVL use across
all calcium morphologies, both in retrospective analyses and
‘real-world’ prospective registries,” said Keith D. Dawkins, MD,
Chief Medical Officer of Shockwave Medical. “This new evidence
showing the consistency of IVL confirms that this platform
technology has a critical role to play in not just concentric
calcium, but in modifying challenging coronary calcium across all
morphologies – whether concentric, eccentric, nodular or
mixed.”
IVL in Eccentric Calcium Published in
Circulation: Cardiovascular Intervention and titled, “Impact of
Calcium Eccentricity on the Safety and Effectiveness of Coronary
Intravascular Lithotripsy: Pooled Analysis from the Disrupt CAD
studies,” the eccentric analysis divided individual patient-level
data (N=230) analyzed by an independent OCT core laboratory into
quartiles from eccentric to concentric based on maximum continuous
calcium arc.
While there were no differences in pre-procedure minimum lumen
area (MLA), diameter stenosis, or maximum calcium thickness across
the different calcium arcs, the calcium length and overall volume
index increased progressively with concentric calcium, and a higher
minimum calcium thickness was increased with eccentric calcium.
Post-procedure, the number of calcium fractures, fracture depth and
width increased with increasing concentricity; however, there were
no significant differences in mean stent area (7.39mm2 vs 7.22mm2
vs 7.26mm2 vs 8.09mm2; p= 0.07) or stent expansion (98.7% vs 100.3%
vs 95.4% vs 101.9%; p=0.74) across quartiles at the site of maximum
calcification. These excellent results were achieved in the absence
of any procedural complications.
“IVL was initially adopted in clinical practice because of its
ability to modify concentric calcium in a safe and predictable
manner, and we are now seeing the utility increase as the
consistency of the safety and efficacy outcomes related to IVL
expand across calcium arcs,” said Dr. Ziad Ali, MD, DPhil, Director
of the DeMatteis Cardiovascular Institute at St Francis Hospital
& Heart Center in Roslyn, NY, USA, and first author on the
publication.* “This shift in clinical practice has been key to
addressing the limitations of atherectomy technologies in modifying
eccentric calcium due to wire bias and the concerns with
perforations associated with high pressure balloons in eccentric
lesions at the interface between the calcium and the healthy
tissue. With IVL, we now have a tool that can modify the eccentric
calcium and increase the vascular compliance to greatest effect
while minimizing procedural risk.”
IVL in Nodular Calcium Published in JACC:
Cardiovascular Interventions and titled, “Safety and Effectiveness
of Coronary Intravascular Lithotripsy for Treatment of Calcified
Nodules,” the patient-level pooled analysis from the Disrupt CAD
studies was the first investigation of IVL in calcified nodules,
examining 54 nodules found within 248 lesions (22%) analyzable by
OCT. In lesions with calcific nodules, IVL was found to be highly
effective in modifying the calcium prior stent implantation,
reducing stenosis to a residual area of less than 15 percent with
an acute gain of 1.8 mm2 in a safe manner with no major procedural
complications.
When comparing lesions with and without calcific nodules treated
with IVL, there were no significant differences in minimum stent
area (6.3mm2 vs 6.0 mm2), mean stent area (8.3mm2 vs 7.9 mm2), or
stent expansion at the maximum site of calcification (104.9% vs
99.4%). There was a trend toward more calcium fractures (78.7% vs
65.2%; p=0.07) in lesions with calcific nodules as well as an
increased fracture length (5.2mm vs 3.6mm p=0.02) in nodular
lesions.
“These new acute data with IVL are very encouraging and
reconfirm the safety of IVL with no procedural complications in
lesions with calcific nodules, which is generally a high-risk
setting, however, there is still a lot to learn about this
challenging calcium morphology to reduce long-term events
associated with calcific nodular protrusion into the stent,” said
Dr. Ali, the first author on the publication. “Given the relatively
low prevalence of nodules, it has been challenging to perform large
prospective controlled studies. The collection of more ‘real-world
data’ in nodules across calcium arcs with intravascular imaging can
help determine the optimal treatment algorithm – whether standalone
IVL or IVL with concomitant technologies – for lesions with
calcified nodules, so that we can improve both short- and long-term
PCI outcomes.”
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 limited for
investigational use in the United States and is CE Marked in the
European Union and the United Kingdom. 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, activities, programs, goals, events or developments
that we expect, believe or anticipate will or may occur, which are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements, other
than statements of historical facts, are statements that could be
deemed forward-looking. 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 plans, 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 to differ
materially from those indicated in the forward-looking statements
include, among others: our ability to design, develop, manufacture
and market innovative products to treat patients with challenging
medical conditions, particularly in peripheral artery disease,
coronary artery disease and aortic stenosis; our ability to
successfully execute our commercialization strategy for our
approved or cleared products; and our expected future growth. 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
*Dr. Ali is a paid consultant of Shockwave Medical. He has not
been compensated in connection with this press release.
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