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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop - ASTM-FDA Workshop on Absorbable Medical Devices: Lessons Learned from Correlations of Bench Testing and Clinical Performance, November 28, 2012

The Food and Drug Administration (FDA) is announcing a public Workshop entitled "ASTM-FDA Workshop on Absorbable Medical Devices: Lessons Learned from Correlations of Bench Testing and Clinical Performance." FDA is co-sponsoring the workshop together with ASTM International, an organization responsible for the development and delivery of international voluntary consensus standards.

The purpose of the workshop is to provide a forum for industry, academia, FDA to discuss test methods for establishing correlations between in vitro and in vivo degradation of absorbable implant devices, and the interaction of mechanical loading and mechanical performance with degradation. While there will be an emphasis on cardiovascular indications as part of a panel session, characterization techniques and experiences from both cardiovascular as well as non-cardiovascular devices will be discussed and are encouraged.

Date, Time and Location

This workshop was held November 28, 2012, beginning at 8:15AM at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center (Great Room, Room 1503)
Silver Spring, MD 20993

Background and Discussion Topics

Recent studies have identified promising results for the use of absorbable materials in implantable devices for endovascular therapies such as fully absorbable cardiovascular stents, where the stent platform degrades, as well as absorbable coatings. The use of these materials for cardiovascular indications poses new risks due to the critical fatigue and mechanical loading demands that the implant must withstand and perform. However, the optimal preclinical/bench testing paradigm to predict clinical performance of fully absorbable cardiovascular devices is not yet defined.   This workshop will discuss the use of absorbable materials (including synthetic polymers as well as erodible metals) in medical devices across a broad range of indications with the aim of defining successful and unsuccessful methods to predict clinical performance, and will subsequently apply these methods to unique challenges for cardiovascular indications. Therefore, we invite presenters to share their experience from cardiovascular and non-cardiovascular medical devices, as well as devices that are fully absorbable, and devices with only a component or coating that is absorbable.   This workshop will bring together the expertise of academia and industry professionals to define test methods as well as to educate and inform their colleagues in industry, academia, and device regulation on the performance and predictability of absorbable medical device degradation. Workshop participants will seek to define the critical factors for preclinical/bench testing and clinical predictability. They will then apply lessons learned from marketed devices for non-cardiovascular indications to the emerging uses of absorbable devices to treat cardiovascular disease.  

Topics to be discussed at the workshop include:

  • Correlations of in vitro and in vivo absorption
  • Quantitative characterization of absorption kinetics
  • Test methods to identify interactions of absorption with mechanical loading and
  • Test methods to assess mechanical performance of the absorbable product

The lessons learned from both early cardiovascular and well-established non-cardiovascular device experiences will be presented. These lessons will be discussed in the context of emerging cardiovascular uses of absorbable materials as part of a panel session at the end of the workshop.

Agenda

TimeSubject
7:30-8:15Registration
8:15-8:30Opening Remarks
8:30-9:30Plenary Presentation
9:30-10:30Session I: Considerations for Modeling Degradation in Vitro Moderator : Hany Demian
10:30-10:45Break
10:45-11:45Session II: In Vitro-In Vivo Correlation (IVIVC) & Predicting Corrosion in Degradable Metals Moderator : Erica Takai
11:45-13:00Lunch on your own Food for purchase will be available
13:00-14:45Session III: In Vivo Performance and In Vitro-In Vivo Correlation (IVIVC) of Polymer Systems Moderator : Ji Guo
14:45-15:00Break
15:00-16:20Session IV:Mechanical Interactions & Product Development Considerations Moderator : Scott Anderson
16:20-16:30Break
16:30-17:30Panel Discussion Moderator : Maureen Dreher

Transcript

Program and Booklet

Contact Us

For questions regarding workshop content please contact:

Maureen Dreher, Ph.D.
Center for Devices and Radiological Health
Food and Drug Administration
WO62-Room 2110
10903 New Hampshire Ave,
Silver Spring, MD 20993,
Phone: 301-796-2505
FAX: 301-796-9932
email: Maureen.dreher@fda.hhs.gov

or

Erica Takai, Ph.D.
Center for Devices and Radiological Health
Food and Drug Administration
WO66-3622
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: 301-796-6353
Fax: 301-796-9959
e-mail: erica.takai@fda.hhs.gov