FDA approves PK Papyrus Covered Coronary Stent System to treat acute coronary artery perforations.- Biotronik

The FDA has approved a device intended to treat acute coronary artery perforations, or tears in the blood vessels of the heart. The PK Papyrus Covered Coronary Stent System from Biotronik is the first device approved by the FDA for this indication in 17 years. �An acute coronary artery perforation is a rare, but potentially life-threatening complication of heart vessel procedures,� said Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices in the FDA�s Center for Devices and Radiological Health. �The PK Papyrus Covered Coronary Stent System provides health care providers with a new treatment option that can seal the perforation in order to stop blood leakage during the procedure and avoid a potentially life-threatening complication or a more invasive surgical procedure.�

The FDA reviewed data for the PK Papyrus System through the humanitarian device exemption process. A Humanitarian Use Device is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects not more than 8,000 individuals in the U.S. per year.

PK Papyrus received European CE Mark approval in 2013.