On November 28th, 2012, a public workshop highlighting and discussing the use of absorbable medical devices across a broad range of indications with the goal of defining successful and unsuccessful methods of predicting clinical performance will be co-sponsored by the FDA and ASTM International, an organization responsible for the development and delivery of international voluntary consensus standards for medical devices and other engineered products (FDA Notice, 77 FR 50113, August 20, 2012). The workshop will focus on the identification of 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. The panel discussion will emphasize cardiovascular indications, but characterization techniques and experiences from both cardiovascular as well as non-cardiovascular devices will be welcome.
According to the FDA, studies have recently shown 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 absorbable coatings. However, the use of these materials poses new risks due to the critical fatigue and mechanical loading demands that the implant must withstand. In addition, the optimal preclinical testing paradigm to predict clinical performance of fully absorbable cardiovascular devices is not yet defined.