Shockwave Medical (SWAV) Disrupt PAD III Results to be Presented in Late-Breaking Session at VIVA20
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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.
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