Objective
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 in addition to a coating. 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, preclinical/bench tests that predict clinical performance of fully absorbable cardiovascular devices are 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 absorption. Participants will subsequently discuss applications of these methods to the unique challenges for cardiovascular indications. Therefore, we invite presenters to share their experience from cardiovascular and non-cardiovascular medical devices that are fully or partially absorbable. Of particular interest are presentations that can address the following topics:

• 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

Workshop participants will apply lessons learned from marketed devices to the emerging uses of absorbable devices to treat cardiovascular disease. From these discussions, workshop participants will seek to define the critical factors for preclinical/bench testing and clinical predictability. 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.

Interested speakers are requested to send a 400 word (maximum) abstract by September 1, 2012 to Workshop Organizers via e-mail to Mary Mikolajewski at mmikolaj@astm.org. Questions about the workshop logistics or technical content may be directed to Maureen Dreher maureen.dreher@fda.hhs.gov or Scott Anderson andersonscotte@hotmail.com.

The language of the workshop will be English. Reasonable accommodations will be made upon request.