BIOTRONIK obtained FDA’s approval, under the Humanitarian Device Exemption, for its PK Papyrus covered coronary stent system. It’s indicated for emergency use when treating acute coronary perforations, both of native vessels and bypass grafts, and is the only device of its kind available to treat vessels between 2.5 mm and 5.0 millimeters in diameter and only 5 French compatible covered coronary stent in the U.S. It has been approved in Europe since 2013.
The stent has a very thin electrospun covering made of polyurethane that keeps blood from pouring through its sides and it’s designed to be very flexible to conform to the vessel during delivery and when positioned within the vessel. “In rare cases of a coronary perforation, time is the enemy,” said Dr. Dean Kereiakes, Interventional Cardiologist and Medical Director of The Christ Hospital and Vascular Center, Cincinnati, Ohio, in a statement. “The device’s superior flexibility and tracking means that PK Papyrus delivers more like a conventional stent and can treat a perforation more quickly, avoiding further complications. Hospitals need to have this potentially lifesaving device ready for physicians to use.”
It’s available in 17 different sizes, which the firm claims helps to give many patients an option over bypass grafts.
Product page: PK Papyrus…