Speaker Abstract: S-04
High-Intensity Focused Ultrasound for Tissue Thermal Ablation: Potential Applications and Critical Path Opportunity
Gerald R. Harris, Ph.D., Center for Devices and Radiological Health/FDA
The critical path initiative can work synergistically with the least burdensome provision of the Food and Drug Administration Modernization Act of 1997 that applies only to devices. A basic principle underlying the least burdensome concept, and also consonant with the critical path model, is that alternative approaches to regulatory issues are to be considered in order to optimize the time, effort, and resources involved in resolving the issues without compromising the scientific integrity of the decision-making process. As an example of how CDRH might employ the critical path approach, the emerging field of high intensity focused ultrasound (HIFU) surgery will be discussed. HIFU is a promising minimally-invasive thermal ablation technique that can be used for localized tumor destruction or cessation of bleeding. The size of the ablation volume depends on the device focusing properties, local temperature reached, and exposure time. Although some clinical success is being achieved, there are no standard methods for prediction and measurement of acoustic and thermal characteristics of the HIFU beam. This presentation will include an introduction to new and potential HIFU device applications, followed by a discussion of CDRH plans to work collaboratively towards standardized test procedures for measuring the properties of HIFU beams, and for predicting the spatial distribution of temperature in tissue. It is expected that the outcome of this effort will lead to CDRH guidance, as well as to input for consensus standards development, both of which should enhance the preclinical testing phase of the regulatory review process. The critical path research opportunities highlighted represent unresolved issues that if solved, could further the development of not only HIFU but perhaps other thermal ablation devices.
2004 FDA Science Forum | FDA Chapter, Sigma Xi | CFSAN | FDA
Last updated on 2004-MAY-28 by frf