Shockwave Confirms Consistent Outcomes for IVL in the Largest Prospective “Real World” Study of Patients with Heavily Calcified Peripheral Arterial Disease
November 01 2022 - 2:45PM
Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the
development of Intravascular Lithotripsy (IVL) to treat severely
calcified cardiovascular disease, announced today that the final
1,373-patient cohort analysis from the Disrupt PAD III
Observational Study (OS) again demonstrates consistent IVL outcomes
in complex and challenging lesions across multiple peripheral
vessel beds. The study represents the largest prospective “real
world” evidence supporting the treatment of complex, heavily
calcified peripheral artery disease (PAD) with IVL. The final
analysis was presented earlier today at VIVA22 in a late-breaking
clinical trial session.
The key findings from Disrupt PAD III OS include:
- IVL resulted in consistent reduction in the diameter of
stenosis with no associated distal embolization, abrupt closure or
thrombotic events at any time
- IVL was the only calcium-modifying therapy used in most cases,
required a limited need for adjunctive therapy tools (i.e., embolic
protection), and had better results with appropriate IVL
sizing
- IVL results were comparable to the previously reported outcomes
from the Disrupt PAD III randomized clinical trial (RCT) showing
that IVL safely and effectively modifies calcium across multiple
peripheral vessel beds
“These consistent results in a ‘real world’ population, combined
with the recent long-term outcomes from the Disrupt PAD III RCT,
reinforce the positioning of IVL as a reliable, potential
first-line therapy for the treatment of large and diverse patient
populations with calcified peripheral arterial disease,” said Ehrin
J. Armstrong, MD, Medical Director, Adventist Heart and Vascular
Institute, St. Helena, CA. “The significant amount of data on IVL
continue to show both consistent efficacy and safety across the
most challenging lesions, various peripheral vessel beds, and even
in the most complex, high-risk patients.”
Disrupt PAD III OS is a prospective, multicenter, single-blind
study of “real world” patients. The analysis looked at the total
1,373-patient cohort enrolled in the study from November 2017 to
June 2021 at 30 global sites. Of the 1,531 lesions treated in the
iliac, common femoral, superficial femoral, popliteal and
infra-popliteal arteries, 90 percent presented with moderate/severe
calcification, with an average calcified length of 115 millimeters.
The use of IVL in these lesions resulted in a final residual
diameter stenosis of 24 percent, similar to Disrupt PAD III RCT (22
percent). Patients also experienced minimal procedural
complications, with only 0.7 percent and 0.2 percent experiencing
final dissections (Type D-F) and perforations, respectively.
Notably, there were no instances of embolization, thrombus
formation, no reflow or abrupt closure.
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 predictably safe way to
significantly improve patient outcomes. To view an animation of the
IVL procedure and for more information,
visit www.shockwavemedical.com.
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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
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internal controls; our financial performance and capital
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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
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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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