Biotronik Begins US Rollout Of PK Papyrus For Coronary Perforations

02 May 2019

The US FDA granted PK Papyrus a humanitarian device exemption (HDE) in late 2018, the first FDA approval of a device to treat coronary perforations since Abbott's Jomed Jostent earned an HDE in 2001.

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Biotronik SE & Co. KG has begun the US launch of the PK Papyrus balloon-expandable covered stent for treating acute perforations of native coronary arteries and coronary bypass grafts.

The US Food & Drug Administration granted a humanitarian device exemption (HDE) for PK Papyrus in September 2018. The...