Stent System Treats Acute Coronary Artery Perforations

The stent is designed to be advanced into the required coronary artery vessel using a balloon catheter to the perforation site. Once deployed, the stent provides a physical barrier to seal the tear in the artery wall, while still allowing blood to flow through it to the myocardium. The PK Papyrus System is intended for vessels 2.5-5.0 mm in diameter, and is available in 17 sizes.

The system was approved by the U.S. Food and Drug Administration (FDA) based on real-world survey data from 80 patients who received the PK Papyrus Stent for a coronary artery perforation. The stents were successfully delivered to the perforation site in 95% of patients, successfully sealing it in 91.3%. There were two deaths during the PCI procedure itslef, and seven patients underwent treatment to drain pericardial fluids. Post-procedure, in-hospital death occurred in five patients with perforations successfully sealed, and in one patient in which the PK Papyrus Stent did not seal the perforation.

“Perforation is very uncommon, but physicians need to be fully prepared for this emergency event. It's unacceptable that this critical care area has seen no innovation in nearly two decades,” said Marlou Janssen, President of Biotronik. “Biotronik saw a need, rose to the occasion, and invested in bringing this stent to the United States. We made this decision because patient care is paramount, and we are committed to helping physicians and hospitals save lives and improve patient outcomes.”

“An acute coronary artery perforation is a rare but potentially life-threatening complication of heart vessel procedures,” said Bram Zuckerman, MD, director of the division of cardiovascular devices at the FDA Center for Devices and Radiological Health (CDRH). “The PK Papyrus Covered Coronary Stent System provides health care providers with a new treatment option that can seal the perforation in order to stop blood leakage during the procedure, and avoid a potentially life-threatening complication or a more invasive surgical procedure.”

The PK Papyrus System is contraindicated for patients not suited for standard PCI procedures, such as those unable to take anti-platelet and/or anticoagulation therapy, patients with allergies to contrast media, patients with uncorrected bleeding disorders, and those with a known allergy or hypersensitivity to amorphous silicon carbide or to any other compound of the PK Papyrus system, including tungsten and nickel.