QUOTED. 3 May 2019. Amy Culley.
Executive Summary
Biotronik started marketing its PK Papyrus balloon-expandable covered stent for treating acute perforations in the US after receiving a humanitarian device exemption from the US FDA last year. See what Biotronik's Amy Culley director of vascular intervention clinical studies said about the device here.
"Biotronik saw a need to develop and rethink how to design a product to have a single stent with a single cover. When you have an emergency situation, you want confidence in the ability to deliver the treatment quickly and effectively. –Amy Culley, director of vascular intervention clinical studies, Biotronik
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