Biotronik Launches PK Papyrus Covered Coronary Stent in the United States
April 10, 2019—Biotronik announced the United States commercial launch of its PK Papyrus covered coronary stent system for use in the emergency treatment of acute coronary perforations.
The company stated that the device features an ultra-thin strut, single-stent design and electrospun polyurethane membrane. It is designed to reduce the high rate of adverse outcomes associated with coronary artery perforations. It is available in 17 sizes and is 5-F compatible.
In September 2018, Biotronik announced FDA approval of PK Papyrus under a humanitarian device exemption for use in the emergency treatment of acute coronary perforations in the United States. PK Papyrus received European CE Mark approval in 2013. PK Papyrus is approved for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter.