Shockwave Disrupt PAD III Results to be Presented in Late-Breaking Session at VIVA20
Shockwave Medical (NASDAQ: SWAV) announced that acute results from the DISRUPT PAD III study will be presented at VIVA20, a virtual conference on November 7, 2020. This study, the largest of its kind, focuses on treating severely calcified peripheral lesions with Intravascular Lithotripsy (IVL). Key outcomes include procedural success, defined by residual stenosis less than or equal to 30% without significant complications. Over 300 patients were enrolled across multiple countries, providing critical insights for challenging vascular treatments.
- The DISRUPT PAD III study is the largest randomized trial for severely calcified peripheral lesions, enhancing the credibility of results.
- The study enrolled 306 patients at 45 sites, indicating robust data collection and potential for significant insights.
- The upcoming presentation at VIVA20 builds anticipation and visibility for Shockwave's IVL technology.
- None.
SANTA CLARA, Calif., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the acute results from the DISRUPT PAD III randomized study have been accepted for presentation in a late-breaking session at VIVA20, being held virtually from November 6-8, 2020.
“Disrupt PAD III is the largest randomized study of severely calcified peripheral lesions ever conducted and includes patients who have generally been excluded from previous peripheral trials. As such, these data will provide important new insights on optimizing vessel preparation for challenging lesions in a core lab adjudicated randomized study,” said Keith D. Dawkins, M.D., Chief Medical Officer of Shockwave Medical. “On behalf of the entire Shockwave team, I want to thank all of the investigators, research coordinators and patients who have supported this study. We look forward to the acute safety and effectiveness results being shared at VIVA20.”
The details of the late-breaking session are as follows:
| Presentation Title: | Disrupt PAD III RCT Acute Results: IVL vs PTA in Severe Calcium | |
| Time: | November 7, 2020 at 7:00 am Pacific Time | |
| Presenter: | Dr. William (Bill) Gray, M.D., FACC, FSCAI, Chief of the Division of Cardiovascular Disease at Main Line Health, Wynnewood, PA; Co-Principal Investigator of DISRUPT PAD III |
Also occurring on November 7, 2020 at VIVA20, Professor Andrew Holden, MBChB, Auckland City Hospital, Auckland New Zealand, will host The Shockwave Symposium: Insights from the DISRUPT PAD III RCT in Severe Calcium, an expert panel discussion of perspectives on the DISRUPT PAD III data. The event is scheduled for 9:50 am Pacific Time.
About DISRUPT PAD III
DISRUPT PAD III is a prospective, multicenter, randomized post-market study designed to demonstrate the safety and effectiveness of the Shockwave Peripheral IVL Catheter as a vessel preparation tool in moderate to severely calcified superficial femoral and popliteal artery lesions. The study enrolled 306 patients. Patients were enrolled at 45 sites in the United States, Germany, Austria and New Zealand. Patients will be followed for two years.
The primary endpoint is procedural success defined as residual stenosis less or equal to than 30 percent without flow-limiting dissection (greater or equal to Grade D) The primary endpoint was assessed by an angiographic core lab after vessel preparation and post-dilatation, if required, and prior to DCB or stent placement.
The co-principal investigators of the study were William A. Gray, M.D. and 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, including statements regarding our product development outlook, 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. Such forward-looking statements are subject to risks, uncertainties, and assumptions about us and are not guarantees of future performance. You are cautioned not to place undue reliance on these forward-looking statements.
Forward-looking statements contained in this press release may include, but are not limited to, statements about: the impact of the COVID-19 pandemic on our operations, financial results, and liquidity and capital resources, including on our sales, expenses, supply chain, manufacturing, research and development activities, clinical trials and employees; 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 expected future growth, including growth in international sales; the size and growth potential of the markets for our products, and our ability to serve those markets; the rate and degree of market acceptance of our products; coverage and reimbursement for procedures performed using our products; the performance of third parties in connection with the development of our products, including third-party suppliers; regulatory developments in the United States and foreign countries; our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines; our plans to research, develop and commercialize our products and any other approved or cleared product; our ability to scale our organizational culture of cooperative product development and commercial execution; the development, regulatory approval, efficacy and commercialization of competing products; the loss of key scientific or management personnel; our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act; our ability to develop and maintain our corporate infrastructure, including our internal controls; our financial performance and capital requirements; and our expectations regarding 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 forward-looking statements are only predictions based on our current expectations and projections about future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. 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. Forward-looking statements we make are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Except to the extent required by law, we do not undertake to update any of these forward-looking statements after the date of this press release to conform these statements to actual results or revised expectations.
| Media Contact: | Investor Contact: |
| Scott Shadiow | Debbie Kaster |
| +1.317.432.9210 sshadiow@shockwavemedical.com | dkaster@shockwavemedical.com |
FAQ
What is the DISRUPT PAD III study related to Shockwave Medical?
When will the results of the DISRUPT PAD III study be presented?
What are the primary endpoints of the DISRUPT PAD III study?
How many patients were involved in the DISRUPT PAD III study?
Who is presenting the DISRUPT PAD III results at VIVA20?
