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Approvals Innovation Cardiology

Biotronik Begins US Rollout Of PK Papyrus For Coronary Perforations

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Executive Summary

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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