Workshop Aims to Assess Emerging Field of Absorbable Medical Devices
Posted 20 August 2012 | By
A new workshop sponsored by US regulatory officials will investigate the use of absorbable materials in medical devices and methods to predict their clinical performance.
Writing in the Federal Register, the US Food and Drug Administration (FDA) said the devices have already shown potential, and noted the possibility of stents that could fully degrade within the body instead of requiring removal at a later point in time. Other devices could be partially absorbable, noted FDA.
While this would represent a "promising" step forward, FDA explained it still has concerns regarding the ability of the devices to hold up to mechanical loading demands and their ability to withstand critical fatigue. "Moreover," FDA wrote, "the optimal preclinical/bench testing paradigm to predict clinical performance of fully absorbable cardiovascular devices is not yet defined."
Regulators said the workshop intends to define what a successful and unsuccessful method to predict clinical performance would take into account. Factors are likely to include the correlation between in vitro and in vivo absorption, quantitative characterization of absorption kinetics, and how to determine if absorption is affecting the structural or performance integrity of the device.
The 28 November workshop will be held at FDA's White Oak Campus.
FDA - ASTM International-Food and Drug Administration Workshop on Absorbable Medical Devices: Lessons Learned From Correlations of Bench Testing and Clinical Performance