September 2021 The FDA has approved the NCDR CathPCI Registry to begin a study of the Shockwave Intravascular Lithotripsy (IVL) System. This post-approval study seeks to capture real-world insights into the IVL system.
What is the Shockwave IVL System?
The Shockwave C2 Coronary IVL Catheter is a catheter balloon that contains lithotripsy emitters (pressure waves) to break up calcification that may be causing narrowing or blockage inside the blood vessels of the heart. The device was approved in February of 2021, and data so far shows promising results for patient survival without further heart attacks and without the need for further treatments at 30 days and 1 year.
How to Participate
Per the NCDR, “Patients in the CathPCI Registry, who received PCI and in whom a Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary IVL Catheter was utilized, should be abstracted in your CathPCI Registry v5 data collection tool addressing all relevant questions as usual. Additionally, the Auxiliary Data Collection Shockwave Intravascular Lithotripsy (IVL) Dataset will need to be completed to engage in this initiative.” Participation is optional, but facilities wishing to engage in this initiative should begin data capture for patients discharged after June 30, 2021. Any data capture prior to this date is at each facility’s discretion.
Data can be captured on the 1-page Shockwave paper data collection form until the data collection tool is available. The data collection form and data dictionary are now available on the CathPCI Registry Documents home page.
Development of the Shockwave Auxiliary dataset is optional for NCDR Certified Software Vendors and technical specifications will be provided to all software vendors when finalized.
If your site is interested in learning more about assistance with this initiative and NCDR registries, please contact us https://www.registrypartners.com/contact/.
NCDR.com – Resources – Meeting Minutes – September 16, 2021