Publications – Particle Counting
Medical Device Testing
The Comprehensive Validation of a Stent Coating Durability Tester
by | RMBS 2009 | Publications, Particle Counting
Ramesh R, Conti JC, Strope ER
RMBS 2009
Keywords: stent, coating, durability, particles, counting, validation
Abstract
This study addresses the need to develop an instrument and supporting protocol to evaluate the tendency for a bare or drug coated stent to shed particles into the vasculature of a patient. The resultant experiments demonstrated that two types of instruments each properly detected, sized and counted better than 90% of the injected calibration particles within four minutes.
A Comprehensive Protocol and Procedural Considerations Designed to Evaluate the Shedding of Particles from Drug Eluting Stents
by | MPMD 2007 | Publications, Particle Counting
Conti JC, E. Strope, R. Ramesh, C. Conti, A. Watkins
MPMD 2007
Abstract
The American Society for Testing and Materials (ASTM) [35] and Association for the Advancement of Medical Instrumentation (AAMI)/ International Organization for Standardization (ISO) [36] committees have drafted or passed standards [38, 39] to address the release of particulates into the vasculature by drug eluting stents during deployment and implantation. A new AAMI…
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