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U.S. Department of Health and Human Services

About FDA

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Research Project: Prosthetic Heart Valves – Cavitation and Percutaneous Delivery

This project involves work on artificial heart valves with the objectives of (1) improving the current test methodology for characterizing the hydrodynamic performance of prosthetic heart valves and (2) improving our understanding of factors that affect such performance. Results of these studies will play a role in the development of heart valve testing guidance and standards, thereby supporting more efficient premarket review and providing focused postmarket follow-up, as necessary.

Toward this end, we can divide the effort into separate studies associated with the work.

  • Cavitation acoustic studies to facilitate the development of a cavitation detection technique to separate the generally higher frequency cavitation acoustic noise and noise produced from the mechanical closing of a valve.
  • Cavitation potential studies are designed to understand the hydrodynamic conditions leading to cavitation with the goal of improving the preclinical cavitation potential test requested of heart valve manufacturers.
  • Percutaneous delivery of heart valves is an emerging technology where appropriate preclinical test methods have not been established.

The initial work from the cavitation acoustic signature studies has been published; the investigation into developing possible preclinical test methods for percutaneous heart valves was determined to be not fruitful. This research project has been closed.