Data from Pharmawand - Curated by EPG Health - Date added 14 April 2019
Biotronik announced the United States commercial launch of the PK Papyrus covered coronary stent system for use in the emergency treatment of acute coronary perforation. The FDA approved the device intended to treat acute coronary artery perforations, or tears in the blood vessels of the heart on 14 September 2018. 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.
The PK Papyrus Stent System is a balloon-expandable covered coronary stent and delivery system. The device is advanced into the perforated coronary artery vessel using a balloon catheter, similar to the one used during the PCI procedure. Once the PK Papyrus Stent is implanted, it provides a physical barrier to seal the tear in the artery wall while still allowing blood to flow through the device to the heart muscle. Successful sealing of a coronary perforation with the PK Papyrus Covered Coronary Stent System can be a life-saving procedure without the need for open-heart surgery.
Comment: PK Papyrus received European CE Mark approval in 2013.