TSurgical Sutures and Yarns
for Permanent Implants
Every medical device for permanent or partial implant
constructed with Lenzing PROFILEN® yarns has to be
certified and approved by regulatory affairs in the region
it is meant to be sold in. Lenzing Plastics itself got certified
with ISO 13485. So far there are no cases where
Lenzing PROFILEN® yarns did not pass the evaluation
and already several devices are sold regularly, starting
from heart valves (class 3 implants) to relatively simple
surgical sutures (sterilized yarn with a needle attached).
This application is not the focus of this article, if you
look for further details, please contact the author