Biotronik has received FDA approval for its PK Papyrus covered coronary stent system.

The PK Papyrus coronary stent system is a balloon-expandable covered stent that is placed in the coronary artery using a balloon catheter delivery system. The stent system is designed to treat tears in heart blood vessels, known as coronary artery perforations. It is manufactured from cobalt-chromium metal alloy and covered with a polyurethane membrane.

PK Papyrus is used to seal the coronary artery perforations in coronary arteries and coronary bypass grafts in vessels that are 2.5 to 5.0 mm in diameter. The system is designed to be permanently implanted at the site of a coronary artery perforation to provide a physical barrier and prevent bleeding from the tear.

The stent has been successful in delivering to the perforation site in 76 of 80 patients (95%) with successful perforation seals in 73 of 80 patients (91.3%).

Biotronik received CE Mark approval for the PK Papyrus in the European Union in 2013.