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Compliance In Focus
Posted by John Lehmann on Thu, May 16, 2013

FDA Spearheading International Transcatheter Valve Registry Consortium

The FDA recently hosted a meeting that included industry, government and medical societyFDA Spearheading International Transcatheter Valve Registry Consortium experts.  The goal of this meeting was to establish a resource for real world data on transcatheter valve replacement technology and also serve as a model for future international cardiovascular device registry collaborations.

An international collaboration of registries would regulate agencies and physicians to:

  • Evaluate risk prediction models more thoroughly than before
  • Improve the process whereby physicians decide if a patient needs a valve replacement or transcatheter procedure
  • Provide a more effective approach to identifying rare but severe adverse events and complications than the current voluntary reporting system

There is already precedent for this type of international collaboration.  The international consortium of Orthopedic Registries, is a group of 29 registries in 14 countries.  The development of national and international device registries and new methods for evidence generation analysis are key goals of a new national post-market surveillance system.

Bram Zuckerman, Director of FDA’s Division of Cardiovascular Devices, feels that bringing key stakeholders together led to a great discussion.  While David Holmes of the Mayo Clinic and vice-chair of the Society of Thoracic Surgeons/American Cardiology TVT registry feels the transcatheter valve registries could serve as a “pilot project for the relationship between professional societies and regulatory agencies”, as published in the Grey Sheet  (Vol 39.No.17).

Holmes indicates that the next step for the group will be to identify a steering committee to govern the collaboration of transcatheter valve registry organizations.  The committee will oversee the pieces of information from the registries and to monitor if the amount of overlap.

There seems to good energy behind this initiative and it has the support of transcatheter valve manufacturers.  What are your thoughts on the initiative and do you believe that this will lead to additional international collaborations?  Share your thoughts below.

Photo Credit: Loren Sztajer

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Topics: Transcatheter Valve Registry, Bram Zuckerman, FDA


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