Stent to seal coronary artery tears cleared

December 13, 2018 0 By FM

The US FDA has cleared PK Papyrus Covered Coronary Stent System, a device to treat acute coronary artery perforations or tears in the blood vessels of the heart.
A coronary artery perforation can occur during Percutaneous Coronary Intervention (PCI) procedures.
The PK Papyrus Stent System is a balloon-expandable covered coronary stent and delivery system. The device is advanced into the perforated coronary artery vessel using a balloon catheter, similar to the one used during the PCI procedure. Once the PK Papyrus stent is implanted, it provides a physical barrier to seal the tear in the artery wall while still allowing blood to flow through the device to the heart muscle. Successful sealing of a coronary perforation with the PK Papyrus Covered Coronary Stent System can be a life-saving procedure without the need for open-heart surgery.
The FDA reviewed real-world survey data from 80 patients who received PK Papyrus stents to treat coronary artery perforations. PK Papyrus stents were successfully delivered to the perforation site in 76 of the 80 patients (95 percent), and the device successfully sealed the perforation in 73 patients (91.3 percent), according to US FDA.