The FDA has approved a device intended to treat acute coronary artery perforations that can occur during percutaneous coronary intervention (PCI) procedures. The PK Papyrus Covered Coronary Stent System (Biotronik) is the first device approved for this indication in 17 years.
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 device can be a life-saving procedure, obviating 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. The 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). There were two deaths that occurred during the PCI procedure, and seven patients underwent treatment to drain a fluid collection around the heart. Post-procedure, in-hospital death occurred in five patients with perforations successfully sealed by PK Papyrus stents and in one patient for whom the PK Papyrus stent did not successfully seal the perforation.
The PK Papyrus system, reviewed under the humanitarian device exemption process, is contraindicated for patients who are not considered candidates for standard PCI procedures, such as individuals unable to take antiplatelet and/or anticoagulation therapy, patients with allergies to contrast media, and patients with uncorrected bleeding disorders. The device is also contraindicated in patients with a known allergy or hypersensitivity to amorphous silicon carbide or any other compound of the product (Siloxane-based Polyurethane, L-605, and cobalt chromium alloy, including tungsten and nickel).
Source: FDA.gov, September 14, 2018