Posted by Michael Wonder on 17 Sep 2018
FDA approves device for treatment of acute coronary artery perforations
17 September 2018 - The U.S. FDA today 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 is the first device approved by the FDA for this indication in 17 years.
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.
