CathPCI Registry Approved For FDA Post-Approval Study on Shockwave IVL System
The U.S. Food and Drug Administration (FDA) has approved ACC’s CathPCI Registry for post-approval studies on the Shockwave Coronary Intravascular Lithotripsy (IVL) System in real-world settings. FDA approved the device in February 2021. The device is used during PCI before stent implantation, to open coronary arteries that are narrowed or blocked due to calcification.
Facilities participating in the CathPCI Registry should abstract data as usual for PCI patients in whom the Shockwave IVL System with Shockwave C2 Coronary IVL Catheter was used. In addition, facilities should complete the new Auxiliary Data Collection Shockwave IVL Dataset for patients with a discharge date after June 30, 2021, to participate in this initiative. The Shockwave data dictionary and data collection form are now available under CathPCI Registry “Documents Home Page” at NCDR.com to support data capture until the Auxiliary Data Collection tool is available. Future updates on this initiative will be available on the registry Announcement page.
Keywords: CathPCI Registry, National Cardiovascular Data Registries, Stents, Calcinosis, Registries, Cardiac Catheters, Lithotripsy, United States Food and Drug Administration, Patient Discharge, Percutaneous Coronary Intervention, Coronary Vessels
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