The PK Papyrus sheathed coronary stent system developed by BIOTRONIK to be used in the emergency treatment of acute coronary perforations in original coronary vessels or those that are bypassed grafts, attained FDA approval under the Humanitarian Device Exemption.

It was already approved in Europe in 2013 and is the only French coronary stent approved in the U.S. It is one of its kinds as it is able to traverse vessels with diameters as narrow as 2.5 mm to 5.0 mm.

The company touts it as an alternative to bypass grafts as it is made in 17 differing sizes.

The covering of the stent is electrospun and is very thin made from polyurethane. This covering prevents the blood from flowing along its sides and its flexibility also enables the stent to transform its shape when delivering and placing it inside 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 mean 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.”