Last Patient Enrolled in DISRUPT CAD III, the U.S. FDA IDE Study for IVL in Severely Calcified Coronary Arteries
SANTA CLARA, Calif., April 06, 2020 — Shockwave Medical, Inc. announced today that the company has completed enrollment in the pivotal U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study – DISRUPT CAD III – for the use of IVL in heavily calcified coronary arteries. The investigational Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter, which has been granted Breakthrough Device Designation by the FDA, is an innovative therapy designed to fracture problematic calcium using sonic pressure waves in order to facilitate stent delivery, deployment and optimal expansion.
The co-principal investigators of the study are Dean Kereiakes, M.D., FACC, FSCAI, Medical Director of The Christ Hospital Heart and Vascular Center and the Christ Hospital Research Institute, Professor of Clinical Medicine, The Ohio State University, and Jonathan Hill, M.D., Consultant Cardiologist at Royal Brompton Hospital in London.
“The speed and ease with which we were able to enroll the study speaks volumes to the value of IVL for treating this challenging group of patients with calcified coronary disease,” said Dr. Kereiakes. “If coronary IVL is shown to be safe and effective, similar to the outcomes demonstrated in the earlier CAD I and CAD II studies, it could be a game changer for the way we treat calcified arteries today.”
DISRUPT CAD III is a prospective, multicenter, single-arm, global IDE study to demonstrate the safety and effectiveness of the Shockwave Coronary IVL System with the Shockwave C2 Coronary IVL Catheter in de novo,calcified, stenotic, coronary arteries prior to stenting. The study enrolled 384 patients, exceeding the minimum requirement of 372 patients, per the a priori statistical plan agreed by the FDA. Patients were enrolled at 47 global sites in the United States, France, Germany, and the United Kingdom.
The DISRUPT CAD III study is assessing freedom from major adverse cardiac events (MACE) within 30 days of the index procedure as the primary safety endpoint. The primary effectiveness endpoint is procedural success defined as stent delivery with a residual stenosis less than 50 percent and without in-hospital MACE.
The study chairman is Gregg W. Stone, M.D., FACC, FSCAI, Professor of Medicine (cardiology) at Icahn School of Medicine at Mount Sinai in New York. The angiographic and optical coherence tomography (OCT) core labs are at the Cardiovascular Research Foundation, also based in New York.
“We eagerly await the opportunity to share the DISRUPT CAD III results with the global interventional community later this year,” said Dr. Hill. “IVL has been a significant advance for our management of calcified lesions in Europe and I am excited about the potential for the technology to have a similar impact in helping patients across the United States.”
‘’Despite the global challenges of COVID-19, the CAD III investigators, research staff and site monitors have done an outstanding job in bringing this important study to a timely conclusion,” said Doug Godshall, President and Chief Executive Officer of Shockwave Medical. “Based on recent collaborative interactions with the FDA, it is our expectation that the PMA will be submitted in the third quarter of this year, with U.S device approval anticipated in the first quarter of 2021, consistent with previous guidance.’’
Shockwave C2 Coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies; they are limited to investigational use in the United States.
About Shockwave Medical, Inc.
Shockwave Medical is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. We aim to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through our differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which we refer 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.