Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the
development of Intravascular Lithotripsy (IVL) to treat severely
calcified cardiovascular disease, announced today that long-term
data from the Disrupt PAD III trial found that superior vessel
preparation with IVL led to excellent long-term outcomes out to two
years with preservation of future treatment options compared to
percutaneous transluminal angioplasty (PTA) in the treatment of
calcified peripheral artery disease. The final outcomes of the
largest randomized trial of severely calcified peripheral lesions
were presented by investigators today in a featured clinical
research session at the 2022 Scientific Sessions of the Society for
Cardiovascular Angiography & Interventions (SCAI) and published
simultaneously in JSCAI.
As previously published, IVL at 30 days demonstrated superiority
over PTA in the primary endpoint analysis, defined as procedural
success with a residual stenosis less than or equal to 30 percent
without flow-limiting dissection, prior to drug-coated balloon
(DCB) or stent, with a rate of 65.8 percent versus 50.4 percent
(p=0.0065) as determined by an independent angiographic core lab.
Additionally, PAD III showed that IVL achieved a reduction in
frequency and severity of flow-limiting major dissections (1.4
percent vs. 6.8 percent, p=0.03), a reduction in stent implantation
rate (4.6 percent vs 18.3 percent, p<0.001) and no distal
embolization or perforation events.
These new long-term results found that the powered secondary
endpoint of primary patency (defined as freedom from CD-TLR,
restenosis determined by duplex ultrasound and provisional
stenting) favored IVL over PTA at one year (80.5 percent vs. 68.0%,
p=0.017) and remained favorable through two years (Kaplan-Meier
estimate: 74.4 percent vs. 57.7 percent, p=0.005),
respectively.
“Prior to the PAD III study, there were limited long-term data
available to provide treatment guidance for this challenging
population since patients with severe calcification have
historically been excluded from endovascular trials,” said William
A. Gray, M.D., FACC, FSCAI, Co-Director of the Lankenau Heart
Institute and System, Chief of the Division of Cardiovascular
Disease at Main Line Health, Wynnewood, PA, and co-principal
investigator of PAD III who presented the long-term results. “The
primary end point at 30 days showed IVL to be a superior vessel
preparation strategy by demonstrating stenosis resolution with
significantly fewer complications including severe dissections and
the subsequent need for bail-out stent implantation. Avoiding
unplanned stent implantations allows interventionalists to preserve
all their future treatment options should reintervention be
necessary. These new long-term data show that vessel preparation
with IVL followed by DCB result in excellent efficacy and durable
patency out to two years, and taken together the acute and
long-term results reinforce IVL as a preferred vessel preparation
strategy for calcified femoropopliteal disease.”
Disrupt PAD III was a prospective, multicenter, randomized study
designed to demonstrate the safety and effectiveness of IVL as a
vessel preparation procedure in moderate to severely calcified
superficial femoral and popliteal lesions, followed by a DCB or
stent. The study enrolled 306 patients randomized between IVL and
PTA at 45 sites in the United States, Germany, Austria, and New
Zealand. In the IVL arm, 82.9 percent of patients were classified
by the angiographic core lab as having severe calcification, with
an average calcified lesion length of 129.4 millimeters. Joining
Dr. Gray as co-principal investigator of the study was Gunnar Tepe,
M.D., Head of the Department of Diagnostic and Interventional
Radiology, RoMed Clinic Rosenheim, Germany.
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 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. 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, and
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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